BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUMATCH GXL 15DEG LINER 36MM SZ J

    MDR report key: 19148056 · Received April 19, 2024

    Report

    Report Number
    1038671-2024-00913
    Event Type
    Injury
    Date Received
    April 19, 2024
    Date of Event
    November 21, 2022
    Report Date
    May 10, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862023407
    PMA / PMN Number
    K051556
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANT DEVICE: 5834507 100-36-00 - 36MM +0MM FEMORAL HEAD. H7: Z-1728-2022. H3. THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR OF THE TIBIAL INSERT. THE CAUSE OF PROTHESIS WEAR IS GENERALLY A COMBINATION OF RISK FACTORS INCLUDING USE ERROR, IMPLANT POSITIONING, IMPLANT SIZE SELECTION, AND PATIENT FACTORS. HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED WITH THE INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 0

    PLEASE DISREGARD THE INITIAL REPORT AS THIS EVENT WAS FOUND TO BE A DUPLICATE OF EVENT REPORTED UNDER MFR# 1038671-2024-00563.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL HIP ON (B)(6) 2020 AND WAS REVISED ON (B)(6) 2022. PATIENT REQUIRED REVISION SURGERY FOR ISSUES INCLUDING BUT NOT LIMITED TO POLYETHYLENE PROSTHESIS WEAR, PAIN, COMPONENT LOOSENING AND DEVICE FAILURE. THE MOSTLY LIKELY CAUSE FOR THE REVISION REPORTED DUE TO PROTHESIS WEAR IS A COMBINATION OF RISK FACTORS INCLUDING USE ERROR, IMPLANT POSITIONING, IMPLANT SIZE SELECTION, AND PATIENT FACTORS. HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED WITH THE INFORMATION PROVIDED. THE SERIAL NUMBER (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-1728-2022 (B)(6) 132-36-29 - ACUMATCH GXL 15DEG LINER 36MM SZ J 510K: K051556 UDI: (B)(4). CONCOMITANT DEVICES: 5834507 100-36-00 - 36MM +0MM FEMORAL HEAD. THE SERIAL NUMBER (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-1728-2022. SERIAL: (B)(6). 132-36-29 - ACUMATCH GXL 15DEG LINER 36MM SZ J 510K: K051556 UDI: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1110974 ACUMATCH GXL 15DEG LINER 36MM SZ J PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. UNK 10885862023407

    Patients

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