BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA IMPLANT PSC INSERT, SZ 1, 13MM

    MDR report key: 18120162 · Received November 13, 2023

    Report

    Report Number
    1038671-2023-02754
    Event Type
    Injury
    Date Received
    November 13, 2023
    Date of Event
    December 13, 2022
    Report Date
    October 22, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862173416
    PMA / PMN Number
    K110547
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: 02-010-01-0210. 2049711. LOGIC FEMORAL PS CEM LEFT SZ 1. 02-012-41-1010. 2200443. LOGIC TIBIA TRAPTRAY CEM SZ 1F/1T. 200-02-29. 2343015. THREE PEG PATELLA 29MM. 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 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, RADIOGRAPHS, AND RELEVANT CLINICAL INFORMATION 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 LEFT KNEE REPLACEMENT ON (B)(6) 2012. THE PATIENT WAS DIAGNOSED WITH MODERATELY SEVERE POLYMERIC-INDUCED SYNOVITIS WITH SEVERE FEMORAL OSTEOLYSIS AND MORE FOCAL TIBIAL OSTEOLYSIS, SYNOVIAL EXPANSION INTO THE GUTTERS EFFACES THE COLLATERAL LIGAMENTS. UNUNITED BONY FRAGMENTS WERE IDENTIFIED ADJACENT TO THE MCL. APPROXIMATELY 10 YEARS AND 6 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2022 DUE TO POLYMERIC-INDUCED SYNOVITIS. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236826 LOGIC TIBIA IMPLANT PSC INSERT, SZ 1, 13MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK 10885862173416

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention SEE H10.