BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUMATCH GXL 15DEG LINER 32MM SZ G

    MDR report key: 18360154 · Received December 19, 2023

    Report

    Report Number
    1038671-2023-03033
    Event Type
    Injury
    Date Received
    December 19, 2023
    Date of Event
    November 30, 2023
    Report Date
    November 4, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862023247
    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

    SECTION H10: (H3) THE MOST LIKELY UNDERLYING CAUSE FOR THE REVISION REPORTED IS A COMBINATION OF RISK FACTORS SPECIFIED IN AN HHE AND BEING IMPLANTED FOR MORE THAN 10 YEARS. HOWEVER, THIS CANNOT BE CONFIRMED FROM THE REPORTED INFORMATION AND THE DEVICES WERE NOT AVAILABLE FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) PENDING EVALUATION: (D10) CONCOMITANT DEVICE(S): 874746 118-01-02 - P-SERIES PF PLASMA COLLARLESS SZ 2 12/14. 678566 120-01-54 - ACUMATCH CLUSTER CUP POROUS COATED 54MM. 885625 120-65-20 - BONE SCREW 6.5MM DIA X 20MM LONG. 702937 148-32-00 - 12/14 ZIRCONIA HEAD 32MM +0MM NECK.

    Additional Manufacturer Narrative · 0

    H6: CORRECTED THE FOLLOWING: HEALTH EFFECT - CLINICAL CODE AND PROBLEM CODE.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 17 YEARS POST OP INITIAL RIGHT THA, THIS FEMALE PATIENT WAS REVISED DUE TO PAIN. CUP WAS REMOVED. COMPETITORS ACETABULAR COMPONENT IMPLANTED. NO ISSUES WITH SURGERY. EXPLANTS NOT AVAILABLE. PRODUCT NOT RETURNING - EXPLANTS NOT AVAILABLE. NO OTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2106141 ACUMATCH GXL 15DEG LINER 32MM SZ G PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. UNK 10885862023247

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female SEE H10.