BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUMATCH A SERIES

    MDR report key: 9758232 · Received February 26, 2020

    Report

    Report Number
    1038671-2020-00221
    Event Type
    Injury
    Date Received
    February 26, 2020
    Date of Event
    January 30, 2020
    Report Date
    April 20, 2020
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862019783
    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 EVALUATION NOTED THAT THE REASON FOR THE REVISION REPORTED MAY HAVE BEEN THE RESULT OF ASEPTIC LOOSENING AFTER BEING IMPLANTED FOR OVER 18 YEARS, WHICH LED TO THE REPORTED MIGRATION OF THE ACETABULAR CUP. HOWEVER, THIS CANNOT BE CONFIRMED DUE TO LIMITED INFORMATION AND THE DEVICES NOT BEING AVAILABLE FOR EVALUATION. (D11) CONCOMITANT DEVICE(S): CEMENTED FINNED TIB. TRA SZ 3F/3T (CN: 200-04-33, SN: (B)(6).

    Description of Event or Problem · 0

    AS REPORTED, THIS MALE PATIENT WAS INITIAL IMPLANTED WITH EXACTECH DEVICES ON AN UNKNOWN DATE, UNKNOWN FACILITY AND UNKNOWN SURGEON. A REVISION SURGERY PERFORMED ON (B)(6) 2001. NO OTHER INFORMATION AVAILABLE ON THE REVISION EXCEPT THAT EXACTECH DEVICES WERE IMPLANTED. THE CURRENT EVENT FOR THIS 70 Y/O MALE PATIENT IS THE ACETABULAR SHELL NEEDED REVISION DUE TO MIGRATING INTO A VERTICAL POSITION. THE CUP/LINER AND TWO SCREWS WERE REMOVED. ACETABULUM WAS REAMED AND COMPETITOR DEVICES WAS IMPLANTED ALONG WITH EXACTECH COCR HEAD 28+5. THE HIP WAS FOUND TO BE STABLE AND WOUND WAS CLOSED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES WILL NOT BE RETURNED DUE TO HOSPITAL POLICY. PHOTO OF EXPLANTED DEVICE WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION. CONCOMITANT DEVICES: 28MM +5 FEMORAL HEAD (CN: 100-28-05, (B)(4)); 28MM 15 DEG LINER SIZE J (CN:132-28-09, SN: (B)(4)); BONE SCREW (CN: 120-65-40, SN: (B)(4)); BONE SCREW (CN: 120-65-20, SN: (B)(4).

    Description of Event or Problem · 1

    AS REPORTED, THIS MALE PATIENT WAS INITIAL IMPLANTED WITH EXACTECH DEVICES ON AN UNKNOWN DATE, UNKNOWN FACILITY AND UNKNOWN SURGEON. A REVISION SURGERY PERFORMED ON (B)(6) 2001. NO OTHER INFORMATION AVAILABLE ON THE REVISION EXCEPT THAT EXACTECH DEVICES WERE IMPLANTED. THE CURRENT EVENT FOR THIS (B)(6) Y/O MALE PATIENT IS THE ACETABULAR SHELL NEEDED REVISION DUE TO MIGRATING INTO A VERTICAL POSITION. THE CUP/LINER AND TWO SCREWS WERE REMOVED. ACETABULUM WAS REAMED AND COMPETITOR DEVICES WAS IMPLANTED ALONG WITH EXACTECH COCR HEAD 28+5. THE HIP WAS FOUND TO BE STABLE AND WOUND WAS CLOSED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES WILL NOT BE RETURNED DUE TO HOSPITAL POLICY. PHOTO OF EXPLANTED DEVICE WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219100 ACUMATCH A SERIES ACUMATCH CLUSTER CUP POROUS COATED 62MM JDI EXACTECH, INC. 120-01-62 10885862019783

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention