BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMET SPLINED KNEE STEM

    MDR report key: 1052086 · Received May 20, 2008

    Report

    Report Number
    1825034-2008-00140
    Event Type
    Malfunction
    Date Received
    May 20, 2008
    Date of Event
    June 4, 2007
    Report Date
    June 4, 2007
    Manufacturer
    BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K915132
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE HAVE BEEN NO TRENDS IDENTIFIED RELATED TO THIS TYPE OF EVENT. OTHER: EVAL OF RETURNED DEVICE FOUND IMPLANT WAS BENT INCORRECTLY AT VENDOR, AND WAS NOT IDENTIFIED DURING RECEIVING INSPECTION. CORRECTIVE AND PREVENTIVE ACTIONS WERE INITIATED. 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 DURING KNEE PROCEDURE IN 2007 WHEN SPLINED STEM WAS OPENED, IT WAS IDENTIFIED THAT THE ANTI-ROTATIONAL PLANE WAS IN THE OPPOSITE POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET SPLINED KNEE STEM JWH BIOMET, INC. NA 066950

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK