BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC FEMORAL PS CEM RIGHT SZ 2

    MDR report key: 18122222 · Received November 13, 2023

    Report

    Report Number
    1038671-2023-02759
    Event Type
    Injury
    Date Received
    November 13, 2023
    Date of Event
    October 12, 2022
    Report Date
    January 28, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001214
    PMA / PMN Number
    K033883
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: 4822623 02-012-44-2011 - LOGIC TIBIA IMPLANT PSC INSERT, SZ 2, 11MM. 4860130 02-012-41-2020 - LOGIC TIBIA TRAPTRAY CEM SZ 2F/2T. 4894640 200-02-32 - THREE PEG PATELLA 32MM. 632522 203-96-52 - STRYKER KMS2512.M62 90X25X1.19MM. 924925 203-96-54 - KOMET BLADE KMS2513.M62 90X25X1.27 STRYKER 5/6/7. 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 FEMORAL LOOSENING AND PROSTHESIS WEAR 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, COMPONENT, AND INVESTIGATION CLINICAL CODES.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6)2017. APPROXIMATELY 5 YEARS AND 4 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2022. 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. REVISION OP REPORT ON (B)(6) 2022. DIAGNOSIS: RIGHT KNEE ASEPTIC LOOSENING. THERE WAS ABUNDANT SYNOVITIS AND INFLAMED AND IRRITATED TISSUES. POLY WAS REMOVED. FEMORAL COMPONENT WAS REMOVED. THIS DID LOOSEN RELATIVELY EASILY AS EXPECTED AND WAS REMOVED WITH MINIMAL BONE LOSS. THE PATIENT WAS AWAKENED FROM ANESTHESIA AND TAKEN TO RECOVERY ROOM IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237961 LOGIC FEMORAL PS CEM RIGHT SZ 2 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK 10885862001214

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention