BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORNIER

    MDR report key: 2201112 · Received April 8, 2011

    Report

    Report Number
    1226487-2011-00002
    Event Type
    Malfunction
    Date Received
    April 8, 2011
    Manufacturer
    TORNIER INC.
    Product Code
    HWC
    PMA / PMN Number
    K990804
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L CATALOG# STA-P4. ADD'L LOT# K10467.

    Description of Event or Problem · 1

    IT IS REPORTED THAT AN IMPLANTED GREAT TOE JOINT PROSTHESIS BECAME DISASSOCIATED/DISASSEMBLED ONE WEEK POST OPERATIVELY. THE DEVICE WAS REMOVED AT A REVISION SURGERY AND REPLACED USING A STANDARD K-WIRE FUSION TECHNIQUE. NO FURTHER PT ISSUES HAVE BEEN REPORTED. DEVICE WAS NOT RETURNED FOR EVAL FROM THE CLINICAL FACILITY, DISPOSITION IS UNK BUT BELIEVED DISCARDED IN ERROR. CAUSE OF FAILURE CANNOT BE DETERMINED WITHOUT THE DEVICE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TORNIER SCREW, FIXATION, BONE HWC TORNIER INC. K09558

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention