The Recalled Total Hip: My Approach The Lawyer is Calling! Michael - PowerPoint PPT Presentation

ADULT RECONSTRUCTION AND JOINT REPLACEMENT The Recalled Total Hip: My Approach – The Lawyer is Calling! Michael B. Cross, MD Assistant Attending Orthopaedic Surgeon

Disclosures • Consultant: • Smith & Nephew • Link Orthopaedics • Exactech Inc. • Intellijoint • Acelity • Theravance Biopharma • Zimmer Biomet • Honorarium • Acelity • Editorial Board • Techniques in Orthopaedics • Bone and Joint Journal 360 • Journal of Orthopaedics and Traumatology ADULT RECONSTRUCTION AND JOINT REPLACEMENT

The Recalled Total Hip – The Problem • From 2002 to 2013, Consumer’s Union found 578 recalls from six major manufacturers 1 ADULT RECONSTRUCTION AND JOINT REPLACEMENT 3

Reasons for Recalls • Recalls can be a result of: – Labeling issues – Manufacturer issues – Packaging issues – Design flaws – Early implant failure – Instruction issues – Missing components – Fractured implants ADULT RECONSTRUCTION AND JOINT REPLACEMENT 4

What did we learn from MOM bearings? ADULT RECONSTRUCTION AND JOINT REPLACEMENT 5

What did we learn from MOM bearings? • Marketing strategies told us MOM and Hip Resurfacings offered: – Large heads for stability – Improved range of motion – Improved tribology – Patients can do what they want! But then… ADULT RECONSTRUCTION AND JOINT REPLACEMENT 6

FDA Guidelines for the asymptomatic recall (MOM)… • Asymptomatic and has a well functioning hip – follow-up should occur periodically (every 1-2 years) • Patient follow-up visits should include: – Physical exam with functional assessment; – Checking for asymptomatic local swelling or masses; and – Assessment for possible systemic adverse events in cardiovascular, nervous, endocrine (especially thyroid) and renal systems • SOFT TISSUE IMAGING (MRI OR U/S) • METAL ION LEVELS – SERUM COBALT AND CHROMIUM\ ADULT RECONSTRUCTION AND JOINT REPLACEMENT 7

NOT ALL ASYMPTOMATIC PATIENTS SHOULD BE WATCHED ADULT RECONSTRUCTION AND JOINT REPLACEMENT

Case: the asymptomatic MOM patient  64 yo F presents in April 2017 s/p right primary metal-on-metal THA implanted in 2007  Completely asymptomatic: no activity restrictions, no pain  Labs from May 2017  Serum Cobalt: 7.4 UG/L  Serum Chromium: 9.3 UG/L  Slowly increasing labs and ”Fluid” on MRI  X-ray revealed mal-positioned cup  Huge concern for increased metal particulate wear over time as a result of cup position  Plan: Revision after discussion with the patient ADULT RECONSTRUCTION AND JOINT REPLACEMENT

FDA Guidelines for the symptomatic MOM patient… • Patient has local symptoms – pain or swelling at or near the hip – a change in walking ability – a noise from the hip conduct a thorough evaluation • Follow-up of symptomatic patients should occur at least every six months • Assess for systemic symptoms • Soft tissue imaging • Serum Cobalt and Chromium levels ADULT RECONSTRUCTION AND JOINT REPLACEMENT 1 The Recalled Total Hip 0

Case: the symptomatic MOM patient • 56 yo F presents in July 2012 s/p left primary metal-on-metal THA implanted in 2006 with minimal pain, but elevated ion levels • Labs from July 2012 – Serum Cobalt: 20.4 UG/L – Serum Chromium: 22.9 UG/L • Returns for repeat labs January 2014 with increasing pain – Serum Cobalt: 42.6 UG/L – Serum Chromium: 32.9 UG/L • MRI revealed moderate/severe ALTR • Plan: Revision Image from Nodzo et al. JoA 2017 ADULT RECONSTRUCTION AND JOINT REPLACEMENT 1 1

What I learned from MOM • Nobody knows what is optimal • Hard-on-hard experience is on-going • Symptomatic patients: – WORK THEM UP !! – Follow them every 6 months until they need a revision • Asymptomatic patients: – Monitor xrays, metal ions, obtain baseline soft tissue imaging and symptoms every 1-2 years – Some patients may want recalled implants out despite being asymptomatic • Not the recommended way to go in all cases ADULT RECONSTRUCTION AND JOINT REPLACEMENT 1 2

Need to Apply what we learned from MOM to all recalls ADULT RECONSTRUCTION AND JOINT REPLACEMENT

Clinical Approach to Recalled Implants • Identify the recalled implant and the number of patients who have received it under your care • Notify all predisposed patients of recall and explain all – Clinical implications – Associated risks – Morbidity – Mortality • Monitor pain, function, and clinical symptoms over time Prophylactic revision surgery, in the absence of evidence of clinical failure, is NOT recommended! ADULT RECONSTRUCTION AND JOINT REPLACEMENT

What are my legal obligations? ADULT RECONSTRUCTION AND JOINT REPLACEMENT

Legal Obligations • RECALL means a firm's removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers and against which the agency would initiate legal action – (Recall does not include a market withdrawal or a stock recovery) • FDA’s 21 Code of Federal Regulations Part 803 (Medical Device Reporting [MDR]): – if a device may have caused or contributed to a death or serious injury, the incident must be reported to the FDA It is our job to ensure medical device reports are submitted for suspected device-associated deaths, serious injuries and malfunctions! ADULT RECONSTRUCTION AND JOINT REPLACEMENT

At HSS… • A hospital wide system is in place to ensure timely reporting • Implant Retrieval Lab – Collection of over 25,000 TJAs, from as early as 1977 – Allows access by investigators researching the performance of total joint replacements – Works in conjunction with Risk Management in the event of recalls, patient requests for hardware, or legal cases ADULT RECONSTRUCTION AND JOINT REPLACEMENT

From the OR to Biomechanics • Following revision hardware stays in Pathology for minimum of 1 week Revision Surgery – Patients can request hardware up to 1 week after DOS Hardware and Tissue to Pathology • ALL total joints and any hardware Pathology for at least 1 week requested for personal or legal reasons is kept Biomechanics Picks Up Hardware Cleaning and Processing in Biomechanics Research, Analysis, Storage or Return to Patient ADULT RECONSTRUCTION AND JOINT REPLACEMENT

From Biomechanics to… Legal Research Request Return to Storage Patient ADULT RECONSTRUCTION AND JOINT REPLACEMENT

Returning Hardware to Patients • Work in tandem with Risk Management for release of any requested implants • Can be requested for – Legal reasons – Personal reasons • Paperwork required to track implants: – Request Form – Chain of Custody Form - hardware may be picked up from physician’s office – Photos of each implant are always taken before release & logged into our Retrieval Database ADULT RECONSTRUCTION AND JOINT REPLACEMENT

Patient Details Physician’s Signature Here Date of Surgery ADULT RECONSTRUCTION AND JOINT REPLACEMENT

Implant Retrieval Algorithm at HSS • IF the implant breaks and causes patient harm, it is reported and sequestered – Manufacturer can be given the option to examine the implant at HSS – Risk management is alerted • If it does not cause harm to the patient, biomechanics will retrieve from pathology – No report is filed and implant is not sequestered – Cataloged as it normally would be ADULT RECONSTRUCTION AND JOINT REPLACEMENT

My approach to the recalled THA • CLINCALLY: – Be up front and communicate clearly with patients – Symptomatic patients: work them up • Serum Cobalt and Chromium ions • Tissue imaging • Monitor them every 6 months – Asymptomatic patients: monitor every 1-2 years if remain asymptomatic unless: • cup malposition • ions rising over time • if you/patient are concerned • LEGALLY: – Remain up to date with institutional protocols and Risk Management procedures – When in doubt, re-direct to Risk Management! ADULT RECONSTRUCTION AND JOINT REPLACEMENT 2 3

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