BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR FEMORAL POR, LEFT, SZ 3.5

    MDR report key: 20907991 · Received December 11, 2024

    Report

    Report Number
    1038671-2024-04779
    Event Type
    Injury
    Date Received
    December 11, 2024
    Date of Event
    January 18, 2024
    Report Date
    December 11, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862158260
    PMA / PMN Number
    K140302,
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REPORT NUMBER: 1038671-2024-00272 D10 CONCOMITANT PRODUCTS: THREE PEG PATELLA 35MM (CAT# 200-02-35 / SERAL# (B)(6)). FEMORAL COMPONENT CR, POROUS SIZE 3.5, L (CAT# 02-010-04-0235 / SERIAL# (B)(6)). FIT TIBIAL TRAY CEMENTED SIZE 3.5F/2.5T (CAT# 02-012-45-3525 / SERIAL# (B)(6)). E1: PHONE NUMBER: (B)(6). G4: 510K K140302, K123687. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1038671-2024-0027. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, FEMORAL LOOSENING, OSTEOLYSIS, AND/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 RELEVANT CLINICAL INFORMATION WERE NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY SEVEN YEARS POST INITIAL LEFT TKA, THE 68 Y/O FEMALE PATIENT WAS REVISED DUE TO OSTEOLYSIS AND POLYETHYLENE WEAR. THE PATIENT EXPERIENCED SYNOVITIS AND IMPLANT PAIN. ALL THE IMPLANTS WERE REMOVED AND REVISED IN TO COMPETITOR¿S PRODUCTS. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES AND X-RAYS ATTACHED. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO THEY WERE DISPOSED AT THE HOSPITAL. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1718799 LOGIC CR FEMORAL POR, LEFT, SZ 3.5 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862158260

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R SEE H11