BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY W/ LOCKING RING 49MM

    MDR report key: 1925629 · Received December 14, 2010

    Report

    Report Number
    1825034-2010-00649
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    November 15, 2010
    Report Date
    November 15, 2010
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    K080642
    Removal / Correction Number
    RES# 57220
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF DEVICE SHOWS THAT THE INFERIOR SIDE HAS ABRASIVE WEAR AND SCRATCHES AROUND THE HOLE. THIS WEAR SUGGESTS THE FRACTURE OCCURRED SOME PERIOD OF TIME BEFORE IMPLANT REMOVAL. POST-FRACTURE DAMAGE HAS OBFUSCATED MOST FRACTURE ARTIFACTS THAT COULD ASSIST IN FINDING A PROBABLE ORIGIN AND CAUSE OF THE TRAY FRACTURE.THE USER FACILITY WAS NOTIFIED OF THE EVENT ON (B)(6) 2010. 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)(6) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A REVERSE SHOULDER PROCEDURE ON (B)(6) 2009. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2010, DUE TO FRACTURE OF THE HUMERAL TRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY W/ LOCKING RING 49MM PROSTHESIS, SHOULDER KWS BIOMET ORTHOPEDICS N/A 551630

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R