BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPR SRS MOD STEM - 12X150MM

    MDR report key: 3792043 · Received May 6, 2014

    Report

    Report Number
    0001825034-2014-03601
    Event Type
    Injury
    Date Received
    May 6, 2014
    Report Date
    April 8, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWT
    PMA / PMN Number
    PK111746
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICAL THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR ASSOCIATED DEVIATION. REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH ISO 11137-2. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 2 STATES, "EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION." THIS REPORT IS NUMBER 1 OF 5 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-03601 / 03605).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A SHOULDER ARTHROPLASTY ON (B)(6) 2013. SUBSEQUENTLY, A REVISION PROCEDURE IS INDICATED DUE TO INFECTION. THERE HAS BEEN NO REPORTED REVISION TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270965 COMPR SRS MOD STEM - 12X150MM PROSTHESIS, SHOULDER KWT BIOMET ORTHOPEDICS N/A 937650

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R