BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIB INSERT IMPL CRC, SZ 4, 9MM

    MDR report key: 17030351 · Received May 31, 2023

    Report

    Report Number
    1038671-2023-01178
    Event Type
    Injury
    Date Received
    May 31, 2023
    Date of Event
    April 21, 2023
    Report Date
    August 15, 2023
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862230485
    PMA / PMN Number
    K123342
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR AS STATED IN THE EXPERIENCE REPORT. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND THE PROVIDED IMAGES DO NOT SHOW SIGNS OF WEAR THAT ARE INCONSISTENT WITH IMPLANTATION. A CONTRIBUTING FACTOR TO THE REVISION MAY HAVE BEEN INCLUSION OF THE IMPLANTED POLYETHYLENE COMPONENT IN THE PACKAGING RECALL. SECTION H11: *THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (H6) COMPONENT CODE: 734, BEARINGS.

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) PENDING EVALUATION (D10) CONCOMITANT DEVICE(S): 4062252 02-010-04-0240 - LOGIC CR FEMORAL POR, LEFT, SZ 4, 3883884 02-012-45-4050 - LGC TIBIAL FIT TRAY CEM SZ 4F / 5T, 4243244 200-02-38 - THREE PEG PATELLA 38MM, 6002016021 A10012 - GPS IMPLANT KIT V2, 402399-18 STK190-119-90 - STRYKER SAW BLADE 90X19X1.19MM.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 6.5 YEARS POST OP INITIAL LEFT TKA, THIS 79 Y/O MALE PATIENT WAS REVISED DUE TO POLY WEAR. SURGEON REVISED LINER AND PETALLA. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. UNABLE TO OBTAIN X-RAYS. PRODUCT NOT RETURNING, DISPOSED BY HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1681816 LOGIC TIB INSERT IMPL CRC, SZ 4, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK UNK 10885862230485

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male