BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY W/LOCKING RING

    MDR report key: 1844083 · Received September 24, 2010

    Report

    Report Number
    1825034-2010-00395
    Event Type
    Injury
    Date Received
    September 24, 2010
    Date of Event
    September 14, 2010
    Report Date
    August 31, 2010
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    K080642
    Removal / Correction Number
    1825034-2010-008R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR.EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA.(B)(4).

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY.EVALUATION OF THE RETURNED COMPONENT FOUND THE FRACTURE ARTIFACTS SUGGEST AN OVERLOAD FRACTURE, BUT POST-FRACTURE DAMAGE OBSCURES THE EVIDENCE OF THE POSSIBLE FRACTURE ORIGIN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT REVERSE SHOULDER ARTHROPLASTY ON (B)(6) 2008. SUBSEQUENTLY, PATIENT TRIPPED ON CARPET AND LANDED DIRECTLY ON HIS OPERATED SHOULDER, AND REVISION WAS PERFORMED ON (B)(6) 2010. HUMERAL TRAY FRACTURE WAS NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT REVERSE SHOULDER ARTHROPLASTY ON (B)(6), 2008. SUBSEQUENTLY, PATIENT TRIPPED ON CARPET AND LANDED DIRECTLY ON HIS OPERATED SHOULDER, AND REVISION WAS PERFORMED ON (B)(6), 2010. HUMERAL TRAY FRACTURE WAS NOTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R