BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXACTECH, INC.

    MDR report key: 10497943 · Received September 5, 2020

    Report

    Report Number
    1038671-2020-00514
    Event Type
    Injury
    Date Received
    September 5, 2020
    Date of Event
    August 21, 2020
    Report Date
    September 3, 2020
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVALUATION NOTED IN 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 INFECTION AND SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION.

    Description of Event or Problem · 1

    AS REPORTED, APPROXIMATELY 8 ½ YEARS POSTOP THE INITIAL IMPLANT, THIS (B)(6) Y/O MALE WEIGHT (B)(6) POUNDS, WAS REVISED FOR POSSIBLE INFECTION AND A LOT OF OSTEOLYSIS OF LEFT KNEE. THE SURGEON REMOVED THESE IMPLANTS BECAUSE OF POSSIBLE INFECTION AND A TREMENDOUS AMOUNT OF OSTEOLYSIS. A SPACER WAS IMPLANTED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES TO BE RETURNED. 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 INFECTION AND SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION. CONCOMITANT DEVICES: (CN: UNK, SN: UNK) TRAP TRAY. (CN: UNK, SN: UNK) PSC POLY. (CN: UNK, SN: UNK) PATELLA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    962381 EXACTECH, INC. FEMORAL COMPOENENT PS JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention