BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUMATCH A SERIES

    MDR report key: 8655326 · Received May 30, 2019

    Report

    Report Number
    1038671-2019-00303
    Event Type
    Injury
    Date Received
    May 30, 2019
    Date of Event
    May 7, 2019
    Report Date
    October 31, 2019
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    PMA / PMN Number
    K993082
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) THE ENGINEERING EVALUATION NOTED THAT THE REVISION REPORTED WAS LIKELY THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE IMPLANT AND THE BONE, WHICH LED TO ASEPTIC (NON-INFECTED) LOOSENING. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION. (D11) CONCOMITANT DEVICES: COCR FEMORAL HEAD (CN: 142-32-10, SN: (B)(6)) ACUMATCH 15 DEGREE LINER, 32MM, SIZE G CN: 132-32-27, SN: (B)(6). BONE SCREW (CN: 120-65-40, SN: (B)(6)).

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION. CONCOMITANT DEVICES: COCR FEMORAL HEAD (CN: 142-32-10, SN: (B)(4)); ACUMATCH 15 DEGREE LINER, 32MM, SIZE G (CN: 132-32-27, SN: (B)(4)); BONE SCREW (CN: 120-65-40, SN: (B)(4)).

    Description of Event or Problem · 1

    THE SURGEON OPENED THE RIGHT HIP IN STANDARD FASHION ON THIS MALE PATIENT. THE SURGEON DISLOCATED THE HIP AND KNOCKED OFF THE FEMORAL HEAD. AFTER RETRACTING SOFT TISSUES, THE SURGEON REACHED IN AND GRABBED THE ACETABULAR SHELL AND LINER WHICH WERE LOOSE. THE SURGEON THEN REAMED THE ACETABULUM AND IMPLANTED A 60 STRYKER CUP AND AN MDM LINER, BUT USED EXACTECH +7 28MM FEMORAL HEAD. THE SURGEON THEN REDUCED THE HIP AND SAW THAT THE PATIENT HAD GOOD STABILITY. WOUND WAS CLOSED IN STANDARD FASHION. THE PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448666 ACUMATCH A SERIES ACUMATCH CLUSTER CUP POROUS COATED 52MM JDI EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention