BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT STD, SZ 1.5, 9 MM

    MDR report key: 14944450 · Received July 7, 2022

    Report

    Report Number
    1038671-2022-00766
    Event Type
    Injury
    Date Received
    July 7, 2022
    Date of Event
    June 16, 2022
    Report Date
    January 31, 2023
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862144331
    PMA / PMN Number
    K111400
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING EVALUATION. CONCOMITANT DEVICE(S): 200-02-29, 4995177 - THREE PEG PATELLA 29MM; 02-012-45-1515, 5395047 - LGC TIBIAL FIT TRAY CEM SZ 1.5F / 1.5T; 02-010-03-0215, 5461982 - LOGIC CR FEMORAL CEM, LEFT SZ 1.5; 02-022-47-1509, 5373513 - TRULIANT TIB IMP CR INS STD SZ 1.5, 9 MM.

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) EVENT HAS BEEN DETERMINED TO BE A DUPLICATE OF CASE-2022-00005290/1038671-2022-00507.

    Description of Event or Problem · 0

    AS REPORTED BY THE LEGAL DEPARTMENT, APPROXIMATELY 2.5 MONTHS POST OP THE INITIAL LEFT TKA, THIS 69 FEMALE PATIENT'S WAS REVISED DUE TO POLYETHYLENE FAILURE. SURGEON WAS ABLE TO REMOVE THE POLYETHYLENE WITHOUT INCIDENT. IT HAD SIGNIFICANT WEAR, MOSTLY ON THE MEDIAL ASPECT OF THE POLYETHYLENE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    966518 LOGIC CR TIB INSERT STD, SZ 1.5, 9 MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. SPECIFIC DEVICE NOT REPORTED UNK 10885862144331

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention