BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUMATCH GXL 15DEG LINER 32MM SZ H

    MDR report key: 17262939 · Received July 5, 2023

    Report

    Report Number
    1038671-2023-01551
    Event Type
    Injury
    Date Received
    July 5, 2023
    Date of Event
    May 12, 2014
    Report Date
    August 19, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862023254
    PMA / PMN Number
    K051556
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. CONCOMITANT MEDICAL PRODUCT: 901773 118-41-03 - P-SERIES PF PLASMA H/O COLLARLESS SZ 3 12/14; 941453 120-01-56 - ACUMATCH CLUSTER CUP POROUS COATED 56MM; 932675 120-65-20 - BONE SCREW 6.5MM DIA X 20MM LONG; 702906 148-32-00 - 12/14 ZIRCONIA HEAD 32MM +0MM NECK. Z-1728-2022.

    Additional Manufacturer Narrative · 0

    H3: BASED ON THE AVAILABLE INFORMATION, THE PATIENT INVOLVED MEETS THE FOLLOWING RISK CRITERIA FOR EARLY PROSTHESIS WEAR/OSTEOLYSIS AS SPECIFIED IN THE HHE: SIGNIFICANT EDGE LOADING OF THE FEMORAL HEAD ON THE ACETABULAR LINER. THE MOST LIKELY CAUSE FOR THE REVISION REPORTED DUE TO EARLY PROSTHESIS WEAR AND OSTEOLYSIS IS A COMBINATION OF THE RISK FACTORS SPECIFIED IN THE HHE. HOWEVER, THIS CANNOT BE CONFIRMED AS NO RADIOGRAPHS OR PHOTOS WERE PROVIDED AND THE DEVICES WERE NOT RETURNED FOR EVALUATION. CORRECTION: H6 CLINICAL CODE AND COMPONENT CODE.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT HAD AN INITIAL THA ON (B)(6) 2007. THE PATIENT WAS REVISED ON (B)(6) 2014; REASON NOT REPORTED. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1786490 ACUMATCH GXL 15DEG LINER 32MM SZ H PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. 132-32-28 10885862023254

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention