BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC

    MDR report key: 17333907 · Received July 17, 2023

    Report

    Report Number
    1038671-2023-01678
    Event Type
    Injury
    Date Received
    July 17, 2023
    Date of Event
    June 22, 2023
    Report Date
    October 12, 2023
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862144409
    PMA / PMN Number
    K111400
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR OF THE TIBIAL INSERT. ROTATIONAL MISMATCH BETWEEN THE FEMORAL AND TIBIAL COMPONENTS AS WELL AS OVERALL POSTERIOR SLOPE OF THE TIBIAL INSERT MAY HAVE CONTRIBUTING FACTORS TO THE WEAR OBSERVED. HOWEVER, THIS CANNOT BE CONFIRMED BECAUSE NO RADIOGRAPHS WERE PROVIDED AND THE REVISED INSERT WAS NOT RETURNED TO EXACTECH FOR EVALUATION. ADDITIONALLY, A CONTRIBUTING FACTOR TO THE TIBIAL INSERT WEAR MAY HAVE BEEN THE RESULT OF BEING PACKAGED IN A NON-CONFORMING VACUUM BAG FOR MORE THAN FIVE YEARS.

    Additional Manufacturer Narrative · 0

    D2B: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL / POLYMER. D10: CONCOMITTANTS: THREE PEG PATELLA 32MM, 200-02-32, LOGIC CR FEMORAL POR, RIGHT, SZ 1.5 02-010-04-0315, (B)(6), LGC TIBIAL FIT TRAY CEM SZ 1.5F / 0.5T 02-012-45-1505. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FEMALE PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2019, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2023, APPROXIMATELY 3 YEARS 11 MONTHS POST THE INITIAL PROCEDURE. THE REVISION WAS DUE TO POLY WEAR. THE LINER WAS EXCHANGED. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO PATIENT HISTORY, X-RAYS, OR DEVICE IMAGES WERE PROVIDED. THE EXPLANTED DEVICE IS NOT AVAILABLE FOR RETURN. THE HOSPITAL DISPOSED OF THE DEVICE. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1615905 LOGIC SEE H10 JWH EXACTECH, INC. LOGIC TIB INSERT IMPL CRC, SZ 1.5, 9MM UNK 10885862144409

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention SEE H10