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Orthopedic Surgery Toolkit

Safety/complications lessons learned

Incomplete pulmonary embolism evaluation alleged to have caused delayed diagnosis and death

This case involves a woman in her mid 40’s, 5’2”, 220 lbs with a history of degenerative arthritis, gastric by-pass surgery (lost 100 lbs), hernia repair, bilateral total knee replacement, fatigue and swelling of her right lower leg. She underwent a left total hip replacement due to degenerative arthritis. She died one week post–operatively from a pulmonary embolism (PE).

Would you agree with the hospitalist’s evaluation and deep vein thrombosis (DVT)/Pulmonary Embolism (PE) prophylaxis?

This patient’s orthopedic surgeon admitted the patient to the hospital for a left total hip replacement. She had been disabled from osteoarthritis for approximately 5 years prior to death. The procedure itself was uneventful. No notes were written in the PACU chart. The surgeon’s post –operative orders were for pneumatic compression devices for both feet and legs. He also ordered Coumadin 5 mg  by mouth for that evening, and 2.5 mg everyday thereafter with instructions to hold Coumadin for PT >16 seconds or INR > 2.5. The preprinted order also specified that nursing was to check circulation in both lower extremities every hour for the first 5 hours and every shift thereafter. {After the lawsuit was filed, a review of the medical record showed gaps in nursing documentation, leading the plaintiff to conclude the nurses didn’t follow the surgeon’s orders.}

The patient was transferred to the floor from the operating room, and referred to a hospitalist to manage her care through discharge. Over night, the patient developed chest pain. The hospitalist’s differential diagnosis included cardiac problems, as well as PE. Myocardial Infarction (MI) was excluded early on. Computed Tomographic Angiography (CTA) was considered to assess for PE, but could not be done because of the patient’s increased creatinine level. The CTA would have required the use of intravenous contrast, contraindicated in a patient with renal insufficiency. The hospitalist felt that a ventilation/perfusion (VQ) scan would be problematic because of having to physically contort a patient who had just undergone hip surgery. In light of the patient being on Coumadin, she didn’t believe that the D-dimer test would provide reliable results. The patient’s chest pain resolved and her oxygen saturation never fell into the hypoxic range.

By post-operative day three, the patient’s creatinine level returned to normal.

Five days later, at midnight, the patient had an oxygen saturation level of 96%. Two hours later, she was noted to be “resting comfortably”. An hour later, she was found unresponsive, and could not be resuscitated.  An autopsy listed the cause of death as a clinically significant PE. In the lawsuit that followed, the plaintiff alleged the hospitalist failed to order appropriate tests to rule out PE, resulting in the patient’s death. With the hospitalist’s consent, the lawsuit was settled for a large amount.

Risk Management Commentary:

Experts opined that there were two major weaknesses in this case:

  1. Although the hospitalist was correct with her initial differential diagnosis including MI and PE as the most likely first and second diagnoses, respectively, the consensus was that there was not enough done after the MI was ruled out to assess for PE.  They agreed with the hospitalist’s decision not to order CTA at the time of her initial exam, because of acute renal failure. However, other things could have been done, such as Doppler ultrasound of the lower extremities; when the patient’s creatinine normalized, a CTA or VQ scan could have been done.
  2. Although the reviewers couldn’t reach a consensus over what specifically would constitute the standard of care for PE prophylaxis, all agreed that the anti-coagulation was insufficient for a high risk patient after major joint replacement surgery. An expert opined Coumadin takes several days to become therapeutic; the use of low weight heparin or Lovenox should have been considered.

Note: Experts reviewed this claim in light of standards and guidelines which were in place at the time. Consider that standards and guidelines for PE prophylaxis change periodically. Providers are strongly urged to keep up with these changes.

[In another claim, involving a patient who developed a fatal PE after discharge home, an Appeals Court ruled that the patient should have been warned about the significance of calf pain, so that she might have been more aggressive in seeking treatment.]

Compartment syndrome case study, the sequelae of a delayed diagnosis

An orthopedic surgeon evaluated a man in the emergency department who had sustained a severely painful injury to his left calf earlier that day. The patient was playing softball when another player slid into him.

The patient complained to the surgeon that his pain was 10/10. He could not weight bear, and his left calf measured at 19 inches compared with a right calf measurement of 16 inches. He had strong pedal pulses with a positive Homan’s sign, and a large bruise over the left calf at the point of impact. After DVT was ruled out by ultrasound, the surgeon released the patient with a diagnosis of “large hematoma.” He was given a prescription for Percocet and discharge instructions to return in two days for an office visit.

The patient returned to the surgeon’s office as directed. At this visit his left calf was edematous with ecchymosis. He experienced pain with dorsiflexion of the left foot. A repeat ultrasound showed no evidence of DVT, but did show evidence of a residual large hematoma.

Four days later, on Saturday, the patient contacted the on-call orthopedic surgeon, requesting an additional prescription for Percocet. The on-call surgeon instructed the patient to go to the emergency department for reevaluation. The patient did go to the emergency department, but to one at a different hospital (hospital #2).

The ED physician at hospital #2 consulted an orthopedic surgeon at that hospital. The surgeon’s clinical impression included left calf hematoma, with possible compartment syndrome. The patient was discharged with a Percocet refill, instructions to keep his left leg in an ace wrap, apply a heating pad, and to return to his regular orthopedic surgeon on Monday. Bothered by the possible diagnosis of compartment syndrome, the ED physician called the on-call orthopedic surgeon at hospital #1. That surgeon requested the ED physician call the patient at home, directing him to report to the ED at hospital #1, as he had instructed the patient that morning. Upon the patient’s return to ED #1, the on-call orthopedic surgeon, with the assistance of a manometer system for monitoring compartment pressures, did diagnose anterior compartment syndrome, and admitted him for immediate surgery.

The patient underwent fasciotomies, with subsequent necrotic muscle debridement and evacuation of the large hematoma. Seven days later he was discharged home.

After discharge the patient continued to have some problems with cellulitis; he was not taking his oral antibiotic as prescribed. He subsequently required a flap and skin grafts. He now has permanent, marked decrease in muscle function in his left leg. He also has permanent foot drop, walks with an impaired gait, and has work restrictions.

The Allegations

The Plaintiff alleged that the first orthopedic surgeon deviated from the standard of care by failing to consider the possibility of compartment syndrome during the ED visit and subsequent office visit, failed to order the necessary test to rule in or rule out compartment syndrome, failed to respond to the plaintiff’s continuous phone calls regarding his pain and failed to perform tests which would have recognized compartment syndrome.

Defense

Experts provided only “thin” support, in part due to lack of documentation by the first orthopedic surgeon, and some classic findings signaling the development of compartment syndrome.

Disposition

The case was settled after mediation for a moderate to large amount.

This classic case emphasizes that compartment syndrome should be thought of early and often in any injury to an arm or leg, with or without fracture, particularly when pain is out of portion to the injury. One has approximately six hours to make the diagnosis, and treat the condition before unfortunate complications such as tissue necrosis occur, leading to severe functional impairment and/or amputation.

  • Fasciotomy in the upper and lower extremities, if done early, can usually be a minor procedure with a small incision; the incision often can be closed loosely by skin alone with a low risk of developing an infection.
  • Late closure is very difficult and late fasciotomy generally does not serve to preserve muscle function after tissue necrosis has occurred.
  • By the time pulselessness, paresthesia or paralysis has resulted, musculature in the extremity has been destroyed, and normal function preservation is often not possible.
  • Compartment syndrome should be ruled out in an arm or leg injury evaluation; do not hesitate to obtain a consultation to confirm or to discount the diagnosis.
  • Document your rationale if you do not believe that compartment syndrome is apparent.
  • Remember, the one “P “that must be dealt with decisively is PAIN OUT OF PROPORTION TO THE INJURY!

Popliteal artery occlusion post knee revision surgery results in above knee amputation

A middle-aged male presented to an orthopedic surgeon with a history of total knee arthroplasty (TKA), commonly known as a. total left knee replacement, the year before with good results. At the time of presentation, his left knee pain was gradually worsening, both at rest and with activity. The surgeon’s impression was the patient was experiencing either loosening of the prosthesis or failed bony in-growth in his left knee, both considered major long-term problems associated with TKA. He recommended knee revision surgery.

In the pre-operative area, the anesthesiologist performed both a femoral nerve block and a sciatic nerve block. The surgery went well with no intraoperative complications. On Post Op Day #1 the patient reported significant pain in his thigh, no feeling or sensation below his knee, and a very hard calf. He also recalled not being able to move his foot, ankle and toes. The nurses and physical therapist  told him this was due to the anesthesia and that it would wear off. Subsequently the patient developed a burning sensation in his left calf, and foot drop. The surgeon’s impression was a complication of sciatic nerve block or perhaps a stretch injury to the peroneal nerve. The surgeon did not note any apparent wound complications. He ordered an ankle-foot orthosis brace to help support the patient’s ankle.

Post Op Day # 2 the patient requested discharge home and the surgeon agreed.

Post Op Day # 3 the Home Health nurse expressed concern over the appearance of the patient’s leg and believed there was something wrong. The nurse did not call the surgeon until Post- Op day #6 (Monday).

Post-Op Day # 4 (Saturday) the patient had called the surgeon’s office with complaints of increasing pain and swelling, but never received a follow up phone call.

Post-Op day # 6 the surgeon found significant left calf swelling and erythemia, however the leg compartments were soft and there was no pain associated with passive stretching. An ultrasound performed to rule out DVT was normal.

Post-Op Day # 8 the patient continued to have burning pain, left leg swelling, persistent numbness below the knee, with erythema and discoloration. He was placed on Keflex and an arteriogram was ordered, as well as a baseline EMG because of the lack of sensation.

The arteriogram was delayed because of insurance authorization requirements, but an arterial ultrasound was performed two days later

Post-Op day # 10 the arterial ultrasound demonstrated an occlusion in the popliteal artery. The patient was admitted to the hospital by a vascular surgeon. After tissue plasminogen actvator (tPA) Therapy failed, the patient had an above knee amputation (AKA) performed.  

Allegations:

  • The Plaintiff alleged the surgeon failed to timely diagnose and treat the popliteal artery occlusion, resulting in AKA.
  • The Plaintiff has also alleged the hospital, nurses and physical therapy staff were negligent in their role to help make a timely diagnosis and treatment of this complication.

Disposition: The case settled in favor of the patient; the doctor, his practice and the hospital paid a very large amount of money.

Risk Management/Patient Safety Commentary

This is a case of misdiagnosis and delay in treatment of popliteal artery occlusion after an uncomplicated total knee revision. It is unknown whether this patient had a history of vascular problems. Although injury to the popliteal artery is a recognized complication of the procedure, and the procedure was performed correctly, this patient was injured by failure to recognize a popliteal artery injury. The vascular literature clearly states that if an arterial occlusion is left untreated for more than 8 hours, the chance of amputation is 86%, compared with an 11% chance if treated within 8 hours.1

  1. Delay in diagnosis/treatment: Experts opined that if the surgeon re-admitted the patient and performed an arteriogram up to post-op day # 3, the occlusion would likely have been discovered, revascularization would have been successful, and the AKA could have been avoided.
  2. Poor medical record documentation: The medical record documentation did not support the orthopedic surgeon or the hospital. The surgeon did not document the patient’s pulses prior to surgery. In his first post-op note, the surgeon indicated an insensate foot, but did not document pulses. The surgeon did not document the appearance of the patient’s skin temperature. The surgeon did not document a differential diagnosis that may have explained his treatment thought processes for delaying the arteriogram.

The experts did not believe the hospital’s physical therapist. actually checked the patient’s post-op pulses. The physical therapist placed a check- mark in a box on a chart template indicating ”positive” palpable pulses. The nurses had not documented the patient’s pedal and popliteal pulses post-operatively. either on the chart template or in their nursing notes.

Reference:

 1 Green NE, Allen BL. Vascular injuries associated with dislocation of the knee. J Bone Joint Surg Am.1977; 59:236–239. 

Resource:

A Review of Knee Dislocations, Andrew Henrichs, J Athl Train. 2004 Oct-Dec; 39(4): 365–369.

Complications from a retained sponge destroys patient’s college basketball plan

An athletic 16 year old male presented to the orthopedic surgeon with complaints of left knee pain following a fall on the basketball court. An MRI revealed left knee anterior cruciate ligament (ACL) rupture, with possible radial lateral meniscus tear, and lateral collateral ligament (LCL) sprain with mild residual instability.   The patient underwent outpatient surgery. One year and 3 months post surgery, a retained sponge was removed by a second orthopedic surgeon. Read more…..

Following an accident on the basketball court, this patient was seen in the hospital ED where he was diagnosed with an acute medial ligamentous left knee strain. He was discharged home with a knee brace, crutches, an anti-inflammatory medication, and a referral to an orthopedic surgeon.

Two days later, the orthopedic surgeon diagnosed a complete tear of his left anterior cruciate ligament (ACL). Five months later the patient underwent a left knee ACL repair under general anesthesia. The sponge count documentation on the operative report was reported as “correct times 2”. Note: Error rates with current manual counting practices are approximately equal to 10-15%; in over 80% of retained sponge cases the count has been falsely called "correct". We characterize these cases as correct count retention cases. These cases are the result of problems with the practice of counting.[i]

At the first post-op evaluation, the patient’s complaints included decreased sensation around the knee, difficulty sleeping and a dislike of the pain medication. The surgeon noted redness around the tibial incision. His impression was that the patient had developed a suture abscess or a superficial wound infection. The patient was started on Keflex for the infection, and placed on Ambien for sleep.

A week later the patient was seen by the surgeon’s partner who was concerned about wound infection, or perhaps an allergic reaction to the surgical pin. There was now drainage from the left knee incision. The patient refused deep wound cultures. The antibiotic was changed to Levaquin, and the patient was advised to monitor the wound daily.

Subsequent post-op visits throughout the summer and fall revealed persistent serous wound drainage, soft tissue swelling and knee instability.  An MRI revealed an ovoid medial knee mass with an intact left ACL graft. The radiologist’s impression was that “given the patient’s history and the appearance of the lesion, this likely represents an organizing hematoma with a thick fibrous capsule. If there is no other intervention, then follow-up is recommended.” The surgeon believed the mass to be a hematoma and advised the patient that this would eventually dissolve. No follow-up study was ordered at that time. At 8 months post-op, the patient reported worsening instability of the knee joint. A rubbery mass continued to be palpable along the medial tibia. The surgeon noted guarding and an inability to pivot the joint with distraction. Twelve months post-surgery, the surgeon ordered an x-ray of the patient’s left knee. The results showed that the mass in his left knee was a retained radiopaque-tagged sponge. The surgeon further explained that he re-reviewed the previous MRI scan but had been unable to see any evidence of a foreign body on that study in any sequence.

Three months later, the patient consulted a second orthopedic surgeon who explored the joint and found a radiopaque surgical sponge, completely encapsulated in abundant scar tissue. Extensive and careful dissection was required, with more tissue removal.

The plaintiff alleged a delay in treatment, resulting in additional scarring, chronic pain, knee mobility problems, crepitus and joint instability, with limitation of his choice of future sports and activities. His plan for a college basketball scholarship could not be realized.

The case was ultimately settled; both the surgeon and the hospital contributed towards the settlement proceeds.

Risk Management Commentary:

We’re continuing to see claims involving retained foreign objects after surgery. The lingering effects of such events can be significant for patients and providers.

In this case, the hospital argued that there was no sponge count policy or procedure in place at the time of the patient’s surgery; therefore the hospital felt that sponge counting was “not their job”. This defense wasn’t effective in reducing the hospital’s exposure. The three main “stakeholders” in preventing retained sponges are surgeonsnurses and radiologists, and communication between all three is a key element. Surgeons and nurses are the primary defenders against retention; radiologists are secondary defenders that mitigate harm. There should be an alliance between the surgeon - whose responsibility it is to remove all surgical items not intended to remain, and the surgical nurses who are responsible for corroborating or refuting the surgeon’s assessment that everything has been removed. Preventing retention is a joint and shared responsibility.

Suggestions for Surgeons and Hospitals:

  • Comply with standardized practices to account for all instruments and items used during surgical procedures.
  • Follow policies and procedures governing counts, identifying and resolving discrepancies immediately, and implementing the other practices to prevent retained surgical items.
  • Ensure that all sponges and other items used during surgical procedures are x-ray detectable.
  • Consider using radio-frequency identification (RFID technology), bar-coding or other technology to supplement surgical item counts.
  • Require that discrepancies be reported to the risk manager
  • Report any adverse events or near misses related to retained surgical items or count discrepancies as part of the facility’s event reporting system.

 

References/Resources:

Association of periOperative Registered Nurses (AORN)

Recommended practices for prevention of retained surgical items. In: 2011 perioperative standards and recommended practices. Denver (CO): AORN Inc; 2011

[i] NoThing Left Behind®: A National Surgical Patient-Safety Project to Prevent Retained Surgical Itemshttp://www.nothingleftbehind.org/Soft_Goods.html; includes “A MultiStakeholder Prevention of Retained Surgical Items Policy”

Disclaimer

The information provided in this resource does not constitute legal, medical or any other professional advice, nor does it establish a standard of care. This resource has been created as an aid to you in your practice. The ultimate decision on how to use the information provided rests solely with you, the PolicyOwner.