BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXACTECH, INC.

    MDR report key: 10677080 · Received October 14, 2020

    Report

    Report Number
    1038671-2020-00571
    Event Type
    Injury
    Date Received
    October 14, 2020
    Date of Event
    September 20, 2020
    Report Date
    December 22, 2020
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) THE EVALUATION NOTED THAT THE REVISION REPORTED BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES. THE CAUSE OF THE INSTABILITY ISSUES AND SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION NO INFORMATION PROVIDED IN THE FOLLOWING SECTION(S): A4, A5, B6. (D4) (CATALOG NUMBER, SERIAL NUMBER, UDI NUMBER, EXP DATE).

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION.

    Description of Event or Problem · 1

    AS REPORTED, APPROXIMATELY 18 YEARS POSTOP THE INITIAL LEFT THA, THIS (B)(6) FEMALE PATIENT, WAS SCHEDULED FOR A REVISION OF THE RIGHT ACUMATCH HEAD - REASON UNKNOWN. ACCUMATCH 11/13 TAPER HEAD 22MM X +3MM, ACCUMATCH HIP PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES SENT TO (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1142113 EXACTECH, INC. ACCUMATCH -5MM X 28MM HEAD JDI EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention