BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUMATCH A SERIES

    MDR report key: 9699795 · Received February 12, 2020

    Report

    Report Number
    1038671-2020-00066
    Event Type
    Injury
    Date Received
    February 12, 2020
    Date of Event
    January 29, 2020
    Report Date
    April 20, 2020
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862019776
    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 WAS LIKELY THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE IMPLANT AND THE BONE, WHICH LED TO ASEPTIC (NON-INFECTED) CUP LOOSENING. HOWEVER, THIS CANNOT BE CONFIRMED AS THE EXPLANTED DEVICES WERE NOT RETURNED FOR EVALUATION (D11) CONCOMITANT DEVICES: - 36MM FEMORAL HEAD (CN: 142-36-93, SN: (B)(6). - 60MM ACETABULAR SHELL (CN: 120-01-60, SN: (B)(6). - 36MM ACETABULAR LINER SIZE J (CN: 132-36-29, SN: (B)(6). - BONE SCREW (CN: 120-65-35, SN: (B)(6). - BONE SCREW (CN: 120-65-35, SN: (B)(6).

    Description of Event or Problem · 0

    AS REPORTED, THE ORIGINAL LEFT TOTAL HIP ARTHROPLASTY ON THIS 76 Y/O MALE PATIENT WAS PERFORMED ON (B)(6) 2007. THIS PATIENT WAS REVISED DUE TO THE ACETABULAR SHELL APPEARS TO BE LOOSE. THE SURGEON OPENED THE PATIENT AND DISSECTED DOWN TO THE JOINT SPACE. HE DISLOCATED THE HIP AND REMOVED THE FEMORAL HEAD, THEN PROCEEDED TO REMOVE THE ACETABULAR SHELL, LINER, AND TWO SCREWS. A COMPETITOR SHELL AND LINER WAS PLACED. HE REPLACED THE PREVIOUS FEMORAL HEAD WITH THE SAME SIZE (36MM -3.5 OFFSET). THE SURGEON WAS HAPPY WITH THESE IMPLANTS AND CLOSED THE PATIENT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES WILL NOT BE RETURNED DUE TO HOSPITAL POLICY.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION. CONCOMITANT DEVICES: 36MM FEMORAL HEAD (CN: 142-36-93, SN: (B)(4)); 60MM ACETABULAR SHELL (CN: 120-01-60, SN: (B)(4)); 36MM ACETABULAR LINER SIZE J (CN: 132-36-29, SN: (B)(4)); BONE SCREW (CN: 120-65-35, SN: (B)(4)); BONE SCREW (CN: 120-65-35, SN: (B)(4)).

    Description of Event or Problem · 1

    AS REPORTED, THE ORIGINAL LEFT TOTAL HIP ARTHROPLASTY ON THIS (B)(6) Y/O MALE PATIENT WAS PERFORMED ON (B)(6) 2007. THIS PATIENT WAS REVISED DUE TO THE ACETABULAR SHELL APPEARS TO BE LOOSE. THE SURGEON OPENED THE PATIENT AND DISSECTED DOWN TO THE JOINT SPACE. HE DISLOCATED THE HIP AND REMOVED THE FEMORAL HEAD, THEN PROCEEDED TO REMOVE THE ACETABULAR SHELL, LINER, AND TWO SCREWS. A COMPETITOR SHELL AND LINER WAS PLACED. HE REPLACED THE PREVIOUS FEMORAL HEAD WITH THE SAME SIZE (36MM -3.5 OFFSET). THE SURGEON WAS HAPPY WITH THESE IMPLANTS AND CLOSED THE PATIENT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES WILL NOT BE RETURNED DUE TO HOSPITAL POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164164 ACUMATCH A SERIES ACUMATCH CLUSTER CUP POROUS COATED 60MM JDI EXACTECH, INC. 120-01-60 10885862019776

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention