BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 13MM

    MDR report key: 16731641 · Received April 13, 2023

    Report

    Report Number
    1038671-2023-00669
    Event Type
    Injury
    Date Received
    April 13, 2023
    Date of Event
    May 10, 2021
    Report Date
    January 7, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862173737
    PMA / PMN Number
    K110547
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION.

    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 INSTABILITY 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 AND RADIOGRAPHS WERE NOT PROVIDED. H6: CORRECTED HEALTH EFFECT, MEDICAL DEVICE, COMPONENT, AND INVESTIGATION CLINICAL CODES.

    Description of Event or Problem · 0

    LEGAL CASE - (B)(6). (B)(4). RELATED CASE: (B)(4). AS REPORTED VIA LEGAL DOCUMENTATION, THIS PATIENT IS VERIFIED LEFT KNEE ON (B)(6) 2016 AND LEFT KNEE REVISION (B)(6) 2021, APPROXIMATELY 4 YEARS, 5 MONTHS AFTER INITIAL SURGERY. POSTOPERATIVE DIAGNOSIS: FAILED LEFT TOTAL KNEE REPLACEMENT SECONDARY TO INSTABILITY AND POLYETHYLENE WEAR. PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. SERIAL #: (B)(4), CATEGORY #: 02-012-44-5013 - LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 13MM, SERIAL NUMBER (B)(4) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. 510K: K110547.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1244711 LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 13MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED JWH EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 13MM UNK 10885862173737

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention