BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUMATCH GXL 15DEG LINER 28MM SZ G

    MDR report key: 15855319 · Received November 23, 2022

    Report

    Report Number
    1038671-2022-01504
    Event Type
    Injury
    Date Received
    November 23, 2022
    Date of Event
    February 25, 2021
    Report Date
    May 13, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862023094
    PMA / PMN Number
    K051556
    Removal / Correction Number
    Z-2121-2021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING EVALUATION. CONCOMITANT DEVICE(S): 0861727, 118-01-02 - P-SERIES PF PLASMA COLLARLESS SZ 2 12/14, 0972299, 148-28-00 - 12/14 ZIRCONIA HEAD 28MM +0MM NECK, 1067269, 120-65-25 - BONE SCREW 6.5MM DIA X 25MM LONG, 1150505, 120-65-25 - BONE SCREW 6.5MM DIA X 25MM LONG, 1151362, 120-65-30 - BONE SCREW 6.5MM DIA X 30MM LONG, 1174342, 120-01-54 - ACUMATCH CLUSTER CUP POROUS COATED 54MM.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION RESULTS - THE REVISION REPORTED IN CASE: (B)(4) MAY HAVE BEEN THE RESULT OF PROSTHESIS WEAR, OSTEOLYSIS, PERIPROSTHETIC FRACTURE, AND ACETABULAR CUP LOOSENING AFTER BEING IMPLANTED FOR OVER 12.75 YEARS. THE PROSTHESIS WEAR MAY HAVE BEEN THE RESULT OF THE ORIENTATION OF THE ACETABULAR CUP, EDGE LOADING/IMPINGEMENT, PATIENT-RELATED CONDITIONS, OR ANY COMBINATION OF THESE POSSIBILITIES. THE ASEPTIC (NON-INFECTED) ACETABULAR LOOSENING MAY HAVE BEEN THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE ACETABULAR CUP AND THE BONE. ADDITIONAL CONTRIBUTING FACTORS TO THE REPORTED FAILURES MAY HAVE BEEN THE RESULT OF A COMBINATION OF THE RISK FACTORS SPECIFIED IN HHE2020-09-11-02 INCLUDING BUT NOT LIMITED TO BEING IMPLANTED WITH A COMPONENT HAVING A SHELF AGE OF GREATER THAN 2 YEARS. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION, AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED AT THE TIME OF THIS EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL THAT 13 YEARS POST OP THE INITIAL RIGHT THA, THIS FEMALE PATIENT WAS REVISED DUE TO SEVERE OSTEOLYSIS, POLY WEAR AND PERIPROSTHETIC FRACTURE. PATIENT WAS HAVING PAIN AND X-RAY REVEALED ACTEBULAR POLY WEAR AND OSTEOLYSIS. SURGEON PERFORMED A REVISION OF THE RIGHT ACETABULAR COMPONENTS AND FEMORAL HEAD. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566682 ACUMATCH GXL 15DEG LINER 28MM SZ G PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. 132-28-27 UNK 10885862023094

    Patients

    Seq Age Sex Outcome Treatment
    1