BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD CR MONO-LCK BEARING 10X71

    MDR report key: 2995411 · Received March 8, 2013

    Report

    Report Number
    0001825034-2013-00551
    Event Type
    Injury
    Date Received
    March 8, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 29, 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

    EVALUATION OF RETURNED DEVICE FOUND IMPLANT TO BE OUT OF DESIGN SPECIFICATIONS. IN REVIEW OF SALES AND COMPLAINT HISTORY, THERE HAVE BEEN NO ADDITIONAL COMPLAINTS OF THE SAME NATURE FOR THIS LOT. ALL OTHER UNITS FOR THIS LOT HAVE BEEN INVOICED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A PRIMARY TOTAL KNEE ARTHROPLASTY ON (B)(6) 2013. DURING THE PROCEDURE, THE SURGEON NOTICED SCRATCHES ON THE TIBIAL BEARING AND DID NOT IMPLANT IT. AS A RESULT A NEW IMPLANT WAS OPENED AND USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99443 VANGUARD CR MONO-LCK BEARING 10X71 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 618700

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R