BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD M UNI FEMORAL LG

    MDR report key: 3090567 · Received May 2, 2013

    Report

    Report Number
    0001825034-2013-01233
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    May 12, 2011
    Report Date
    April 5, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HRY
    PMA / PMN Number
    PK011138
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. THIS EVENT WAS PREVIOUSLY REPORTED ON MANUFACTURER REPORT NUMBER 1825034-2013-00468.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT AN OXFORD KNEE ARTHROPLASTY ON (B)(6) 2003. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(46 2011 DUE TO AN UNKNOWN REASON. IT IS UNKNOWN WHICH COMPONENTS WERE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192991 VANGUARD M UNI FEMORAL LG PROSTHESIS, KNEE HRY BIOMET ORTHOPEDICS N/A 031810

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R