BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUMATCH GXL 15 DEG +5 LAT LINER 36MM SZ H

    MDR report key: 25071705 · Received May 4, 2026

    Report

    Report Number
    1038671-2026-00531
    Event Type
    Injury
    Date Received
    May 4, 2026
    Date of Event
    April 7, 2026
    Report Date
    May 4, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862024824
    PMA / PMN Number
    K051556
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: 120-01-58 - ACUMATCH CLUSTER CUP POROUS COATED 58MM 1536440, 120-65-20 - BONE SCREW 6.5MM DIA X 20MM LONG 1678228, 142-36-03 - COCR FEM HEAD 36MM +3.5 OFFSET 12/14 1496801, 160-21-18 - P-FIT SPLINE PLAS EX-OFF SZ 18 0861783. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICE WAS RETURNED FOR EVALUATION; FURTHER, PHOTOGRAPHS AND/OR RADIOGRAPH IMAGES WERE NOT PROVIDED FOR REVIEW. OPERATIVE NOTES AND/OR MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW OF USAGE/TECHNIQUE. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PREVIOUSLY UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY. OVER TIME, THE POLYETHYLENE COMPONENT EXHIBITED WEAR, AND THE PATIENT EXPERIENCED ASSOCIATED PAIN. A REVISION PROCEDURE WAS PERFORMED. THE FEMORAL STEM WAS ASSESSED INTRAOPERATIVELY AND FOUND TO BE STABLE AND WELL-FIXED; THEREFORE, IT WAS RETAINED. THE PATIENT WAS REVISED TO AN EXACTECH BIOLOX OPTION FEMORAL HEAD AND ADAPTER. THE ACETABULAR LINER WAS EXCHANGED TO A COMPETITOR¿S DEVICE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181731 ACUMATCH GXL 15 DEG +5 LAT LINER 36MM SZ H PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. 10885862024824

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Hospitalization SEE H11