BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 3 13MM

    MDR report key: 18985115 · Received March 27, 2024

    Report

    Report Number
    1038671-2024-00676
    Event Type
    Injury
    Date Received
    March 27, 2024
    Date of Event
    July 25, 2023
    Report Date
    December 13, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001825
    PMA / PMN Number
    K033883
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    1038671-2024-04829, 1038671-2024-04827, 1038671-2024-04826 THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1038671-2024-04829, 1038671-2024-04827, 1038671-2024-04826. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, TIBIAL LOOSENING, AND FEMORAL LOOSENING OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. ADDITIONALLY, THESE DEVICES APPEAR TO HAVE BEEN IMPLANTED FOR OVER TEN YEARS PRIOR TO THE REPORTED EVENT. 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. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. THESE DEVICES ARE USED FOR TREATMENTS, NOT DIAGNOSIS. THERE IS NO OTHER INFORMATION AVAILABLE. SERIAL # NOT CONFIRMED. 2013904 02-012-35-3013 - LOGIC TIBIA PS MOD INSERT SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. 2181315 02-012-35-3013 - LOGIC TIBIA PS MOD INSERT SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2012 AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6)2023 APPROXIMATELY 11 YEARS AND 3 MONTHS AFTER INITIAL IMPLANT. THERE IS NO SPECIFIC DEVICE INFORMATION PROVIDED. NO IMAGES OF THE DEVICES ARE PROVIDED. THE DEVICE WILL NOT BE RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441095 LOGIC TIBIA PS MOD INSRT SZ 3 13MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862001825

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention| H