BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VANGUARD DCM CR TIBIAL BEARING

    MDR report key: 1052098 · Received May 20, 2008

    Report

    Report Number
    1825034-2008-00151
    Event Type
    Malfunction
    Date Received
    May 20, 2008
    Date of Event
    January 15, 2008
    Report Date
    January 17, 2008
    Manufacturer
    BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K023546
    Removal / Correction Number
    1825034-2008-004R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL OF RETURNED DEVICE DETERMINED IMPLANT DID NOT MEET DESIGN SPECS. IN RESPONSE TO RECENT FDA AUDIT, RETROSPECTIVE REVIEW WAS PERFORMED, EVENT WAS REASSESSED AND DETERMINED TO MEET REPORTING REQUIREMENTS AS DEVICE MALFUNCTION. CORRECTIVE AND PREVENTIVE ACTIONS HAVE BEEN INITIATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT UNDERWENT TOTAL KNEE ARTHROPLASTY IN EARLY 2008. DURING THE PROCEDURE, TIBIAL BEARING LABELED AS 183448 LOT 743430, 18 X 71/75 WAS OPENED AND PACKAGE CONTAINED TIBIAL BEARING MARKED LOT 743470, 14 X 79/83.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VANGUARD DCM CR TIBIAL BEARING JWH BIOMET, INC. NA 743430

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK