BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY WITH LOCKING RING 44MM

    MDR report key: 2122338 · Received June 13, 2011

    Report

    Report Number
    1825034-2011-00502
    Event Type
    Injury
    Date Received
    June 13, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 19, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    K080642
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER TEN STATES, "FATIGUE FRACTURE OF COMPONENT CAN OCCUR AS A RESULT OF LOSS OF FIXATION, STRENUOUS ACTIVITY, MALALIGNMENT, TRAUMA, NON-UNION, OR EXCESSIVE WEIGHT." ALTHOUGH POST FRACTURE DAMAGE HAS OBFUSCATED SOME ARTIFACTS, THE FRACTURE APPEARS TO HAVE STARTED IN FATIGUE AND FAILED IN A FAST-FRACTURE. THE USER FACILITY WAS NOTIFIED OF THE EVENT ON (B)(6), 2011. TO DATE, A RESPONSE HAS NOT BEEN RECEIVED FROM THE USER FACILITY. IN THE EVENT THAT THE USER FACILITY SUBMITS A MEDWATCH REPORT, BIOMET WILL FORWARD A COPY TO THE FDA. THIS REPORT SUBMITTED (B)(4), 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT REVERSE SHOULDER ARTHROPLASTY ON (B)(6), 2009. SUBSEQUENTLY, THE PATIENT SUSTAINED A FALL AND HEARD A SNAP FROM THE SHOULDER. THE PATIENT WAS REVISED ON (B)(6), 2011, DUE TO FRACTURE OF THE HUMERAL TRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY WITH LOCKING RING 44MM PROSTHESIS, SHOULDER KWS BIOMET ORTHOPEDICS N/A 848310

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R