BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC FEMORAL PS CEM LEFT SZ 6

    MDR report key: 17478832 · Received August 8, 2023

    Report

    Report Number
    1038671-2023-01890
    Event Type
    Injury
    Date Received
    August 8, 2023
    Date of Event
    July 13, 2023
    Report Date
    February 4, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001184
    PMA / PMN Number
    K093360
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) PENDING EVALUATION. (D10) CONCOMITANT DEVICE(S): 02-012-35-6011 LOGIC TIBIA PS MOD INSRT SZ 6 11MM 2867456; 02-012-45-6050 - LGC TIBIAL FIT TRAY CEM SZ 6F / 5T 4047710; 200-02-38 - THREE PEG PATELLA 38MM 4092607; 203-96-21 - (11-2714) STRYKER 2000 90X13/21X 1.9MM 57323; A10007 - GPS KNEE IMPLANT KIT 1016015025.

    Additional Manufacturer Narrative · 0

    THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR AND FEMORAL LOOSENING OR DUE TO 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, RADIOGRAPHS, AND RELEVANT CLINICAL INFORMATION WERE NOT PROVIDED. H6: CORRECTED HEALTH EFFECT, COMPONENT, AND INVESTIGATION CLINICAL CODES.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 8 YEARS POST OP INITIAL LEFT TKA, THIS 56 Y/O MALE PATIENT WAS REVISED DUE TO A LOOSENING FEMUR. PATIENT ALSO COMPLAINED OF KNEE PAIN. EXPLANTED AND REVISED WITH COMPETITORS DEVICE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. UNKNOWN MEDICAL HISTORY. NO PHOTOS OR X-RAYS PROVIDED. PRODUCT IS NOT BEING RETURNED DUE TO HOSPITAL POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1457745 LOGIC FEMORAL PS CEM LEFT SZ 6 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK UNK 10885862001184

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male