by Olga Maystruk, Designer and Brand Strategist, and
Jennifer Templin, Risk Management Representative
Presentation
In April 2016, a 67-year-old man came to Orthopedic Surgeon A for right knee pain and stiffness. The patient had a history of knee pain and a total right knee arthroplasty 10 years earlier. His history included atherosclerosis, untreated sleep apnea, and a 50-year history of smoking.
Orthopedic Surgeon A recommended inpatient total knee arthroplasty revision and prescribed varenicline for smoking cessation. The procedure was rescheduled twice, and ultimately canceled due to multiple failed nicotine tests. The patient did not return to Orthopedic Surgeon A.
In July 2016, the patient sought care from Orthopedic Surgeon B for right knee pain. The patient’s x-rays showed loosening of the tibial component of the prosthesis with subsidence and malposition into a varus alignment. Orthopedic Surgeon B recommended a hinge knee brace and revision arthroplasty. The patient was instructed to stop smoking and given a prescription for varenicline.
Physician action
On September 5, 2016, Orthopedic Surgeon B ordered lab tests to prepare for the scheduled surgery on September 10. The surgeon did not do a smoking assessment or nicotine test and instead referred to Orthopedic Surgeon A’s workup from April. Orthopedic Surgeon B’s records stated that the patient had not been smoking for two months and was cleared for surgery.
On September 12, the patient was admitted to the hospital for the total revision right knee arthroplasty with hardware placement. The procedure went well without complications. Intraoperative imaging confirmed good positioning and alignment of instrumentation and showed excellent stability extension and flexion.
The patient was discharged home with a prescription for cefadroxil, a muscle relaxer, and a nerve pain reliever and instructed to follow up with outpatient physical therapy within two weeks.
On September 18, one day after discharge, the patient was taken to the emergency department (ED) by ambulance after falling at home and opening the wound. Orthopedic Surgeon B performed emergent irrigation and debridement and wound closure. He noted complete dehiscence of the wound and implant exposure. The patient was given a gentamicin injection in the ED, but no cultures were obtained intraoperatively.
Postoperatively, the patient developed pneumonia and pulmonary edema with pleural effusion and fluid overload and was admitted to the ICU. He underwent a left cardiac catheterization due to diastolic heart failure, selective coronary angiography, and femoral angiogram with vascular closure device.
After a week in the hospital, the patient was discharged to a skilled nursing facility for orthopedic aftercare and pain management, in addition to managing his other health issues.
On October 7, the patient was discharged from the skilled nursing facility and saw Orthopedic Surgeon B. The patient used a brace and a wheelchair for mobility and reported stiffness and swelling around his right knee. Imaging studies showed the arthroplasty components in place and proper alignment of the hardware. Orthopedic Surgeon B instructed the patient on home health aftercare and recommended physical therapy twice a week for six weeks.
When the patient visited Orthopedic Surgeon B two months later, a soft tissue exam was documented as normal. The patient was instructed to follow up in two months.
On January 19, 2017, the patient underwent transcatheter aortic valve replacement for severe aortic stenosis, hypertension, central pulmonary edema, mild basilar atelectasis, and a possible accompanying effusion. Two days later, he was discharged with a rolling walker and a referral to physical therapy for a 12-week outpatient cardiac rehab program.
On February 10, the patient visited an internal medicine (IM) physician with reports of a blister with bleeding and a large red effusion forming on his right knee. The IM physician noted an open wound at the top of the incision with deep tunneling. He obtained a culture. The IM physician told the patient to go to the ED due to a possible septic knee.
The patient later stated that he called Orthopedic Surgeon B’s office when he noticed the blister, left a message, and proceeded to go see the internist. On his way home from the internist’s visit, he received a call from the orthopedic office and was told that he did not need to worry about the blister. Orthopedic Surgeon B disputed this statement, and said his office would have instructed the patient to go to the ED. The patient did not go to the ED.
Three days later, Orthopedic Surgeon B evaluated the patient and observed serous fluid in the knee. He noted an elevated C-reactive protein (CRP) of 32. This lab result was interpreted as a non-specific inflammatory marker. The patient was instructed to follow up in 10 days. The culture ordered by the internist showed a mix of non-predominating organisms of questionable significance. Orthopedic Surgeon B felt the result signified skin flora or contamination.
Over the next two months, the patient’s knee wound condition fluctuated between wound drainage improvement and discomfort with discharge. Orthopedic Surgeon B prescribed several courses of cefadroxil and scheduled an incision and drainage (I & D) procedure for April. He noted the possibility of revision of the total knee arthroplasty.
On April 24, 2017, Orthopedic Surgeon B performed an I & D with debridement of scar tissue and polyethylene exchange. He obtained wound cultures and biopsied the synovial tissue. No purulence or excessive fluid was noted. The patient received vancomycin.
The Orthopedic Surgeon B consulted an infectious disease (ID) specialist to assess the patient for a possible prosthetic joint infection with low virulence organism. The ID specialist ruled out this possibility due to negative intraoperative cultures and synovial tissue specimen not containing any bacterial DNA. The ID specialist recommended discharge on antibiotics with close clinical follow up and wanted to see the patient in the office in two weeks.
Orthopedic Surgeon B planned to discharge the patient on oral antibiotics, but discharge was delayed. Per the nursing notes, they had difficulty contacting Orthopedic Surgeon B to obtain discharge orders.
The patient was upset by the delays and left the hospital against medical advice with no discharge instructions or prescriptions for antibiotics.
In May, the patient returned to Orthopedic Surgeon B, who felt he was showing improvement and that the hardware was stable with good alignment. He debrided eschar and recommended wet-to-dry dressing. He ordered home health care; prescribed oxycodone acetaminophen 5/325 mg and doxycycline 100 mg; recommended using a short knee immobilizer; and instructed the patient to keep his leg straight.
In June, Orthopedic Surgeon B noted wound dehiscence and eschar on the right lateral knee and prescribed baclofen, oxycodone acetaminophen, and hydrocodone. Over the course of the next few visits, Orthopedic Surgeon B noted decreased drainage and incision wound size. The patient’s wound was redressed, and baclofen prescribed.
On July 15, 2017, the patient sought treatment with a wound care specialist for non-healing right knee wound. The patient reported applying povidone iodine 10% ointment daily to the wound. The patient mentioned he had stopped smoking since the September surgery. The physician observed increased drainage, swollen knee, and exposed hardware and ordered labs. The labs were positive for coagulase-negative staphylococci and proteus mirabilis. The physician prescribed cefuroxime axetil and recommended the patient follow up with Orthopedic Surgeon B and the ID specialist to determine if the hardware should be removed.
The patient did not pick up the prescription until a week later and did not promptly contact Orthopedic Surgeon B or the ID specialist. When he returned to the wound care physician, he was advised the hardware likely needed to be removed. The patient initially refused to return to Orthopedic Surgeon B but eventually did see him one final time and advised that he would be seeking a second opinion.
In August 2017, the patient returned to Orthopedic Surgeon A for a second opinion. The physician observed delayed wound healing with a chronic infection in the prosthetic. Orthopedic Surgeon A recommended a spacer and gastrocnemius myocutaneous flap with reimplantation to restore ambulatory function and suggested a suppressive antibiotic regimen to optimize recovery. He urged the patient not to delay surgery and referred him to a plastic surgeon for evaluation.
Almost three months later, the patient saw the plastic surgeon. Two weeks later, on November 27, 2017, Orthopedic Surgeon A and Plastic Surgeon A performed removal of the left total knee arthroplasty hardware, debridement and washout, and placement of a fusion antibiotic spacer. Orthopedic Surgeon A was not able to fully close the distal medial capsule over the tibia where a significant sinus tract was located. Plastic Surgeon A performed the flap and skin graft procedure. Cultures were obtained and the patient was put on empiric cefepime, then switched to ceftriaxone when cultures showed proteus mirabilis.
Two days later, the patient became short of breath and was placed on a bilevel positive airway pressure machine and given furosemide. The patient’s condition improved within a few days, and he was cleared for discharge to a skilled nursing facility, where he was treated for almost six weeks.
In February 2018, the patient consulted Plastic Surgeon A about a planned second surgery by both surgeons for re-elevation of the muscle flap, removal of the antibiotic spacer, and placement of a formal implant. The patient’s well-healed skin graft was in place with no evidence of wound breakdown or drainage. The patient still had chronic edema and induration in the right knee. Plastic Surgeon A recommended strict elevation of the knee a week before the surgery and referred the patient to physical therapy for formal graduated compression wrapping for better tissue and skin laxity for surgical closure.
On March 5, the patient was admitted for the scheduled surgery. The patient did well postoperatively but was evaluated by nephrology for acute kidney injury due to urine retention. The patient was cleared for discharge to a skilled nursing facility, but before discharge, Plastic Surgeon A evaluated the patient and wanted to keep him for additional monitoring.
Plastic Surgeon A removed the vacuum-assisted closure (VAC) dressing and noted epidermolysis and necrosis of the mid-segment of the vertical incision.
A week later, the patient was taken to the OR for irrigation and debridement and wound VAC placement.
On March 23, the patient was transferred to a skilled nursing facility where he continued treatment with VAC changes for eventual skin graft.
The patient saw both Plastic Surgeon A and Orthopedic Surgeon A several times over the next few weeks. After approximately 10 days in the skilled nursing facility Plastic Surgeon A noted little progress in overall healing. There was no granulation tissue and dry desiccated extensor mechanism tendon on the wound base. Plastic Surgeon A discussed treatment options that included complex free tissue transfer and above the knee amputation. The patient asked for time to consider his options.
On April 8, the patient was admitted to the ED due to cellulitis of the right knee wound. Orthopedic Surgeon A and Plastic Surgeon A recommended above the knee amputation to rid the patient of his chronic pain and infection. The patient agreed and Orthopedic Surgeon A performed the surgery the next day. The patient had multiple subsequent wound healing complications but was eventually released back to a skilled nursing facility almost 6 weeks later.
The patient now uses a prosthesis and does home physical therapy.
Allegations
The patient filed a lawsuit against Orthopedic Surgeon B alleging failure to diagnose and treat right knee infection resulting in a subsequent amputation of the right leg above the knee.
Legal implications
While the experts for the defense believed the initial surgery and postoperative treatment were within the standard of care, they were critical of Orthopedic Surgeon B’s actions months after the procedure when the wound was presenting serous drainage.
Independent consultants, the plaintiff’s expert, and the defense experts all echoed that a more aggressive treatment should have been pursued in February 2017. They were also critical of Orthopedic Surgeon B for not ordering a work up and cultures that would have identified the specific organism and the appropriate antibiotic to treat it. Orthopedic Surgeon B also did not consult an ID specialist despite the elevated CRP of 32.
Additionally, there were a few inaccuracies in Orthopedic Surgeon B’s documentation which made the case difficult to defend. Several of the patient’s visits included documentation that appeared to be copied over from visit to visit and did not accurately reflect the patient’s presenting symptoms.
Experts for the defense acknowledged that the patient’s pre-existing and co-existing conditions predisposed him to significant infections that ultimately led to his right leg amputation. The patient’s severe atherosclerosis caused by a 50-year smoking habit largely contributed to his improper wound healing. There was also a question of whether the patient actually quit smoking before the surgery. Since Orthopedic Surgeon B did not order a nicotine test, the patient’s smoking status was difficult to establish.
Disposition
The case was settled on behalf of Orthopedic Surgeon B.
Risk management considerations
In this case, the patient had comorbidities and a history of non-compliance and that likely contributed to a higher risk of complications and a lengthier recovery. The surgeon’s record did not consistently include documentation of the patient’s noncompliance. Ensuring that the patient’s chart includes documentation of these potential challenges can be beneficial for those treating the patient.
When determining whether a patient is a candidate for surgery, documenting what steps have been taken to ensure the patient meets the surgical criteria can be critical. Further, it allows the surgeon the opportunity to consider further evaluation for any criteria that may be in question before surgical intervention. In this case, the surgeon relied on prior investigations of smoking status; it was unclear that the patient had truly stopped smoking.
Documentation was also an issue in this case. State medical boards have rules and regulations surrounding chart documentation and medical record keeping. It is strongly recommended that physicians comply with their state medical boards concerning chart documentation and medical record keeping.
It was noted by consultant reviewers that the orthopedic surgeon’s medical records appeared “cloned”; the patient’s current condition and examination findings were not accurately documented. In a study of more than 20,000 closed claims between 2010 and 2019, several specific electronic health record (EHR) issues were identified. In claims that involved EHR, 72 percent were attributed to EHR documentation errors.1 At minimum, it is recommended to review the following EHR fields with the patient at each visit:
- current medications;
- social/family history;
- medical history;
- allergies; and
- problem list.
While using templates and cloning documentation from prior visits are often used to save time, ensure that the documentation is reviewed with the patient at each visit to verify that the information is accurate. Telephone calls to and from the patient should also be consistently documented the medical record. In this case, there were disputes regarding what instructions the patient received from the surgeon’s staff. Thorough documentation can assist in the defense of a claim.
Additionally, the patient may not have been compliant with his treatment plan. However, his chart does not appear to reflect noncompliance.
Source
1. Leventhal R. Malpractice Claims Report: EHR Documentation Errors Still Far Too Common. Healthcare Innovation website. November 4, 2020. Available at https://www.hcinnovationgroup.com/clinical-it/electronic-health-record-electronic-medical-record-ehr-emr/news/21161325/malpractice-claims-report-ehr-documentation-errors-still-far-too-common. Accessed October 4, 2023.
Olga Maystruk can be reached at olga-maystruk@tmlt.org.
Jennifer Templin can be reached at Jennifer-templin@tmlt.org.
