BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-MOD BIPOLAR 22.2/-4MM HEAD

    MDR report key: 2458692 · Received February 17, 2012

    Report

    Report Number
    0001825034-2012-00140
    Event Type
    Injury
    Date Received
    February 17, 2012
    Report Date
    January 19, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MJT
    PMA / PMN Number
    PK960363
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE - REVISION PROCEDURE SOMETIME IN 2008. 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 WARNINGS IT STATES, "EXCESSIVE ACTIVITY, TRAUMA, AND WEIGHT GAIN HAVE BEEN IMPLICATED WITH PREMATURE FAILURE OF THE IMPLANT BY LOOSENING, FRACTURE, AND/OR WEAR." THE USER FACILITY WAS NOTIFIED OF THE EVENT ON FEBRUARY 16, 2012. IN THE EVENT THAT THE USER FACILITY SUBMITS A MEDWATCH REPORT, BIOMET WILL FORWARD A COPY TO THE FDA. THIS REPORT IS NUMBER 1 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-00140 THRU 00143).

    Description of Event or Problem · 1

    PATIENT UNDERWENT TOTAL SHOULDER ARTHROPLASTY ON (B)(6) 2001. SUBSEQUENTLY, PATIENT WAS REVISED IN 2008 DUE TO PARTICLES IN THE JOINT AND GOUGES IN THE BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIO-MOD BIPOLAR 22.2/-4MM HEAD PROSTHESIS, SHOULDER MJT BIOMET ORTHOPEDICS N/A 310230

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R