BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT SLOPE +, SZ 1.5, 9 MM

    MDR report key: 17070863 · Received June 6, 2023

    Report

    Report Number
    1038671-2023-01248
    Event Type
    Injury
    Date Received
    June 6, 2023
    Date of Event
    December 14, 2022
    Report Date
    July 25, 2023
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862144379
    PMA / PMN Number
    K111400
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON INVESTIGATION THIS HAS BEEN DISCOVERED TO BE A DUPLICATE CASE, ALL NEW/ADDITIONAL INFORMATION WILL BE APPROPRIATELY PROCESSED AND REPORTED UNDER MFR# 1038671-2023-00740.

    Additional Manufacturer Narrative · 0

    D2B: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER. D10. CONCOMITANTS: 4695534, 02-010-03-0315 - LOGIC CR FEMORAL CEM, RIGHT, SZ 1.5; 5545398, 200-02-29 - THREE PEG PATELLA 29MM; 5602889, 02-012-45-1515 - LGC TIBIAL FIT TRAY CEM SZ 1.5F / 1.5T. H6. INVESTIGATION RESULTS- THE LOGIC DEVICE WITH SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. THE CAUSE OF THE PATIENT'S CONDITION AND REVISION SURGERY AS RELATED TO THE DEVICES CANNOT BE CONCLUSIVELY DETERMINED, INSUFFICIENT INFORMATION. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. THERE IS NO OTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2019 AND THEN APPROXIMATELY 3 YEARS, 10 MONTHS LATER, ON (B)(6) 2022, THEY EXPERIENCED A REVISION SURGERY FOR UNREPORTED REASONS. 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
    1233658 LOGIC CR TIB INSERT SLOPE +, SZ 1.5, 9 MM SEE H10 JWH EXACTECH, INC. 02-012-48-1509 10885862144379

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention