BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VG CR MONO-LCK BRG 12X83

    MDR report key: 3205961 · Received July 3, 2013

    Report

    Report Number
    0001825034-2013-02513
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    April 25, 2011
    Report Date
    June 6, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK060525
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT ENROLLED IN THE MONOLOCK TIBIAL COMPONENT CLINICAL STUDY, UNDERWENT A TOTAL KNEE ARTHROPLASTY ON (B)(6) 2009. A SUBSEQUENT REVISION WAS PERFORMED ON APRIL 25, 2011 DUE TO INSTABILITY. THE BEARING WAS REMOVED AND REPLACED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305661 VG CR MONO-LCK BRG 12X83 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 563990

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R