BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R/H MALLORY HEAD STS MODULAR CALCAR

    MDR report key: 1052092 · Received May 20, 2008

    Report

    Report Number
    1825034-2008-00146
    Event Type
    Malfunction
    Date Received
    May 20, 2008
    Date of Event
    October 11, 2007
    Report Date
    October 15, 2007
    Manufacturer
    BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K031693
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. FURTHERMORE, RECORDS SHOW THAT ALL SEGMENTAL LOCKING SCREWS WERE ISSUED TO THE WORK ORDER. THERE HAVE BEEN NO TRENDS IDENTIFIED RELATED TO THIS TYPE OF EVENT. 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 HIP PROCEDURE ON (B) (6) 2007, WHEN STEM PACKAGE WAS OPENED, THERE WAS NO SCREW INCLUDED IN PACKAGE. ADD'L STEM WAS OPENED AND SCREW WAS USED TO COMPLETE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 R/H MALLORY HEAD STS MODULAR CALCAR LPH BIOMET, INC. NA 956890

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK