BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VG CRL MONO-LCK BRG 10X83

    MDR report key: 3172444 · Received June 17, 2013

    Report

    Report Number
    0001825034-2013-01972
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 20, 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
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. 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 PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY (B)(6) 2008. A SUBSEQUENT REVISION WAS PERFORMED (B)(6) 2013 DUE TO INSTABILITY. THE BEARING AND PATELLA WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272824 VG CRL MONO-LCK BRG 10X83 PROTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 957050

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R