BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK TOTAL KNEE SYSTEM, HI-FLEX ASYMMETRIC POSTERIOR-STABILIZED

    MDR report key: 15540892 · Received October 4, 2022

    Report

    Report Number
    1038671-2022-01240
    Event Type
    Injury
    Date Received
    October 4, 2022
    Date of Event
    June 2, 2022
    Report Date
    November 19, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001887
    PMA / PMN Number
    K033883
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: 2323787 200-02-32 - THREE PEG PATELLA 32MM; 2416222 204-04-44 - TRAPEZOID TIBIAL TRAY SZ 4F/4T; 2891294 02-010-01-0340 - LOGIC FEMORAL PS CEM RIGHT SZ 4; 33039 203-96-01 - (11-2222) SAW BLADE NEW STRYK (.050); 43326 203-96-03 - (11-2216) SAW BLADE NEW STRYKER (.050). RECALL: Z-0021-2022.

    Additional Manufacturer Narrative · 0

    H3: BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN ISSUES. THE CAUSE OF THE SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED, INSUFFICIENT INFORMATION.

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. F6 &F8 IS NA- THIS IS A MANUFACTURER'S REPORT.

    Additional Manufacturer Narrative · 0

    1038671-2024-04433 A2: ADDED INFORMATION: DATE OF BIRTH B1: CORRECTED THE FOLLOWING: TYPE OF REPORT (CHECK ALL THAT APPLY) D1: CORRECTED THE FOLLOWING: BRAND NAME D6A: CORRECTED THE FOLLOWING: IF IMPLANTED, GIVE DATE D10: (B)(6) 200-02-32 - THREE PEG PATELLA 32MM (B)(6) 204-04-44 - TRAPEZOID TIBIAL TRAY SZ 4F/4T (B)(6) 02-010-01-0340 - LOGIC FEMORAL PS CEM RIGHT SZ 4 (B)(6) 203-96-01 - (11-2222) SAW BLADE NEW STRYK (.050) (B)(6) 203-96-03 - (11-2216) SAW BLADE NEW STRYKER (.050). G1: CORRECTED THE FOLLOWING: REPORTING CONTACT FIRST NAME, REPORTING CONTACT LAST NAME H6: CORRECTED THE FOLLOWING: HEALTH EFFECT - CLINICAL CODE, IMPACT CODE, MEDICAL DEVICE PROBLEM CODE, COMPONENT CODE, TYPE OF INVESTIGATION. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, TIBIAL LOOSENING, AND DISASSEMBLY OF THE SCREW HOLE CAPS FROM THE TIBIAL TRAY. AN ADDITIONAL FACTOR TO THE REVISION SURGERY MAY HAVE BEEN INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED. SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT HAD AN INITIAL TKA ON (B)(6) 2014. THE PATIENT WAS REVISED ON (B)(6) 2022 DUE TO UNKNOWN REASONS. NO OTHER INFORMATION REPORTED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED VIA LEGAL FILING- APPROXIMATELY 7 YEARS, 6 MONTHS AFTER INITIAL IMPLANT, THE PATIENT UNDERWENT RIGHT KNEE REVISION SURGERY DUE TO ACCELERATED AND PREVENTABLE WEAR OF THE OPTETRAK LOGIC PS POLYETHYLENE TIBIAL INSERT. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2045670 OPTETRAK TOTAL KNEE SYSTEM, HI-FLEX ASYMMETRIC POSTERIOR-STABILIZED PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. 02-012-35-4009 10885862001887

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male Required Intervention SEE H10| SEE H11