BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK TIBIAL INSERT, POSTERIOR STABILIZED

    MDR report key: 10661605 · Received October 12, 2020

    Report

    Report Number
    1038671-2020-10034
    Event Type
    Injury
    Date Received
    October 12, 2020
    Date of Event
    February 11, 2008
    Report Date
    October 9, 2020
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A KNEE REVISION SURGERY ON (B)(6) 2008, DUE TO INFECTION. INITIAL SURGERY DATE WAS NOT REPORTED, NOR WAS LATERALITY OF SURGERY. NO ADDITIONAL INFORMATION ABOUT THE EVENT, OR PATIENT HAS BEEN PROVIDED. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. IN A REVIEW OF THE LABELING AND IFU 700-096-004 REV. N, IT IS A KNOWN COMPLICATION THAT INFECTION, BOTH DEEP AND SUPERFICIAL MAY REQUIRE A SECOND SURGICAL INTERVENTION OR REVISION. ALSO, AS PART OF THE PRE-OPERATIVE ASSESSMENT, THE SURGEON MUST ENSURE THAT NO BIOLOGICAL, BIOMECHANICAL, OR OTHER FACTORS EXIST THAT MIGHT ADVERSELY AFFECT THE SURGERY AND/OR THE POSTOPERATIVE PERIOD. REVISIONS OR SURGICAL INTERVENTIONS ARE A KNOWN COMPLICATION FOUND IN JOINT REPLACEMENTS. ALL PATIENTS SHOULD BE INSTRUCTED ON THE LIMITATIONS OF THE PROSTHESIS, THE PATIENT SHOULD BE CAUTIONED TO MONITOR ACTIVITIES AND PROTECT THE REPLACED JOINT FROM UNREASONABLE STRESSES AND FOLLOW THE WRITTEN INSTRUCTIONS OF THE PHYSICIAN WITH RESPECT TO FOLLOW-UP CARE AND TREATMENT. AS PART OF THE PREOPERATIVE ASSESSMENT, THE SURGEON MUST ENSURE THAT NO BIOLOGICAL, BIOMECHANICAL, OR OTHER FACTORS EXIST THAT MIGHT ADVERSELY AFFECT THE SURGERY AND/OR POSTOPERATIVE PERIOD. REVISIONS OR SURGICAL INTERVENTIONS ARE A KNOWN COMPLICATION FOUND IN JOINT REPLACEMENTS. ALL PATIENTS SHOULD BE INSTRUCTED ON THE LIMITATIONS OF THE PROSTHESIS, AND THE POSSIBILITY OF SUBSEQUENT SURGERY. THE PATIENT SHOULD BE CAUTIONED TO MONITOR ACTIVITIES AND PROTECT THE REPLACED JOINT FROM UNREASONABLE STRESSES, AND FOLLOW THE WRITTEN INSTRUCTIONS OF THE PHYSICIAN WITH RESPECT TO FOLLOW-UP CARE AND TREATMENT. THE SURGEON MUST BE FULLY KNOWLEDGEABLE ABOUT ALL ASPECTS OF THE SURGICAL TECHNIQUE TO USE THE IMPLANTS IN ACCORDANCE WITH THE INDICATIONS AND CONTRAINDICATIONS AND BE TRAINED ACCORDING TO THE PROPER USE OF THE SYSTEM INSTRUMENTATION AND IMPLANTS. IT IS A KNOWN COMPLICATION THAT A PATIENT'S AGE, WEIGHT, OR ACTIVITY LEVEL WOULD CAUSE THE SURGEON TO EXPECT EARLY FAILURE OF THE SYSTEM. AS NOTED IN "WHY ARE TOTAL KNEE ARTHROPLASTIES FAILING TODAY - HAS ANYTHING CHANGED AFTER 10 YEARS?" THE TOP FIVE REASONS FOR TOTAL KNEE ARTHROPLASTY REVISION/SURGICAL INTERVENTION ACCOUNT FOR APPROXIMATELY 85% OF THE REASONS THAT DRIVE REVISION/SURGICAL INTERVENTION. THE FAILURE MECHANISMS ARE AS FOLLOWS: 39.9% FOR LOOSENING; 27.4% FOR INFECTION; 7.35% FOR INSTABILITY; 4.7% FOR PERIPROSTHETIC FRACTURE, AND 4.5 % FOR ARTHROFIBROSIS. IN EARLY REVISIONS (LESS THAN TWO YEARS) INFECTION WAS FOUND TO BE THE MOST COMMON FAILURE MECHANISM AND LATE REVISIONS SHOW ASEPTIC LOOSENING AS THE MOST COMMON REASON. 1 1. SHARKEY, P. L. (2014, SEPTEMBER). WHY ARE TOTAL KNEE ARTHROPLASTIES FAILING TODAY - HAS ANYTHING CHANGED AFTER 10 YEARS?; THE JOURNAL OF ARTHROPLASTY, 29. INFECTION IS A CLINICALLY WELL-KNOWN POTENTIAL COMPLICATION OF ANY SURGICAL PROCEDURE INCLUDING KNEE ARTHROPLASTY. IF INFECTION OCCURS AFTER KNEE REPLACEMENT, WHETHER RELATED TO THE PROCEDURE OR OTHERWISE, THE FOREIGN METAL AND PLASTIC IMPLANTS CAN SERVE AS A SURFACE FOR THE BACTERIA TO LATCH ONTO, INACCESSIBLE TO ANTIBIOTICS. EVEN IF THE IMPLANTS REMAIN WELL FIXED, THE PAIN, SWELLING, AND DRAINAGE FROM THE INFECTION MAKE THE REVISION SURGERY NECESSARY. WITH CURRENT SURGICAL TECHNIQUES AND ANTIBIOTIC REGIMENS, THE RATE OF INFECTION FOLLOWING TOTAL KNEE ARTHROPLASTY RANGES FROM 0.4% TO 2.5%.2 THE HIGHEST RISK PERIOD FOR INFECTION IS BETWEEN SIX MONTHS AND THREE YEARS. 3 2. P.B. VOLETI, K.D. BALDWIN, AND GWO-CHIN LEE. "USE OF STATIC OR ARTICULATING SPACERS FOR INFECTION FOLLOWING TOTAL KNEE ARTHROPLASTY: A SYSTEMATIC LITERATURE REVIEW." THE JOURNAL OF BONE AND JOINT SURGERY. SEPT 2013; 95-A: 1594-9. 3. J.B. MEDING, M.A. RITTER, K.E. DAVIS, AND A. FARRIS. "MEETING INCREASED DEMAND FOR TOTAL KNEE REPLACEMENT AND FOLLOW-UP: DETERMINING OPTIMAL FOLLOW-UP". THE BONE AND JOINT JOURNAL. NOV 2013; 95-B: 1484-9. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES. THE KNEE INFECTION REPORTED WAS LIKELY THE RESULT OF PATIENT CONDITIONS. THERE HAS BEEN NO PATIENT INFORMATION PROVIDED; THEREFORE, THE PATIENT RISK/CLINICAL FACTORS CANNOT BE ASSESSED. THIS EVENT IS BEING REPORTED AS PART OF A LARGE GROUP OF MDR REPORTABLE EVENTS (386) RECEIVED FROM THE HOSPITAL FOR SPECIALTY SURGERY (HSS). EXACTECH ENGINEERING BECAME AWARE OF UNREPORTED REVISIONS OF EXACTECH KNEE PRODUCT VIA A PUBLISHED ABSTRACT AND POSTER (PAPER 640 WHAT HAPPENED? EXTREME DELAMINATION AND OXIDATION IN MODERN DAY COMPRESSION MOLDED POLYETHYLENE BRIAN T. NICKEL, MD, NEW YORK, NY LYDIA WEITZLER, MS, NEW YORK, NY DOUGLAS E. PADGETT, MD, NEW YORK, NY TIMOTHY M. WRIGHT, PHD, NEW YORK, NY. EXACTECH ENGINEERING REQUESTED ACCESS TO THE HSS'S DETAILS REGARDING THE DATA USED FOR THE PUBLICATION. THE KNEE ENGINEERING TEAM RECEIVED RAW DATA FROM HSS DOCUMENTING 386 MDR REPORTABLE EVENTS (REVISIONS) THAT OCCURRED AT HSS FROM 2001 THROUGH JANUARY 2018. HSS DID NOT REPORT THESE EVENTS INDIVIDUALLY TO EXACTECH AT THE TIME OF THE REVISIONS. EXACTECH ENGINEERING FORWARDED THE INFORMATION TO THE EXACTECH COMPLAINT HANDLING UNIT. EACH INDIVIDUAL EVENT HAS BEEN ADDED TO THE COMPLAINT DATA AND INVESTIGATED. CAPA (B)(4) WAS OPENED TO ADDRESS THIS ISSUE AND TO INVESTIGATE AND REPORT THESE EVENTS. AS PART OF THE CAPA, A RISK ASSESSMENT WAS CONDUCTED TO COMPARE THE RATE OF KNEE REVISIONS BEFORE AND AFTER ADDING THE ADDITIONAL REVISIONS FROM HSS TO THE COMPLAINT DATA. THE RISK ASSESSMENT CONCLUDED THAT THE OVERALL OCCURRENCE RATE REMAINS AT A RATING OF VERY LOW (1) PER EXACTECH'S RISK MANAGEMENT PROCEDURE. THE OVERALL RISK PROFILE OF THE DEVICE HAS NOT CHANGED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A KNEE REVISION SURGERY ON (B)(6) 2008, DUE TO INFECTION. INITIAL SURGERY DATE WAS NOT REPORTED, NOR WAS LATERALITY OF SURGERY. NO ADDITIONAL INFORMATION ABOUT THE EVENT, OR PATIENT HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1125322 OPTETRAK TIBIAL INSERT, POSTERIOR STABILIZED OPTETRAK TIBIAL INSERT, POSTERIOR STABILIZED JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S