BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-MOD 54X22MM HD 4MM OFFSET

    MDR report key: 3180719 · Received June 20, 2013

    Report

    Report Number
    0001825034-2013-02094
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    May 24, 2013
    Report Date
    May 29, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    PK992889
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF RETURNED DEVICE FOUND THE CAUSE OF THE FRACTURE IS UNKNOWN DUE TO POST FRACTURE DAMAGE. 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 DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 9 STATES, "FATIGUE FRACTURE OF COMPONENT CAN OCCUR AS A RESULT OF LOSS OF FIXATION, STRENUOUS ACTIVITY, MALALIGNMENT, TRAUMA, NON-UNION, OR EXCESSIVE WEIGHT."

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT AN INITIAL HEMI-SHOULDER ARTHROPLASTY ON (B)(6) 2003. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2013 DUE TO A HEAD FRACTURE. THE SURGEON REVISED FROM A HEMI-SHOULDER TO A REVERSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280651 BIO-MOD 54X22MM HD 4MM OFFSET PROSTHESIS, SHOULDER KWS BIOMET ORTHOPEDICS N/A 783540

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R