BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOUNDATION KNEE SYSTEM

    MDR report key: 2012306 · Received February 2, 2011

    Report

    Report Number
    1644408-2011-00061
    Event Type
    Malfunction
    Date Received
    February 2, 2011
    Date of Event
    July 21, 2010
    Report Date
    July 21, 2010
    Product Code
    JWH
    PMA / PMN Number
    K932425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT WAS ORIGINALLY REPORTED AS THE SCREW STRIPPED OUT OF THE TIBIA DURING TRIALING. AFTER RECEIVING MORE INFORMATION, IT WAS FOUND THE SCREW WAS STRIPPED DURING SURGERY. THE DEVICE WAS NOT RETURNED TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORD FOR ALL DEVICES SHOWED NO DISCREPANCIES IN MANUFACTURING OR PROCESSING OF THESE PARTS. THE MATING THREADS ON ALL SUBJECT PARTS WERE INSPECTED AND WITHIN ORIGINAL MANUFACTURING LOTS, ACCEPTED AND SUITABLY DOCUMENTED AS SUCH. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY WAS CONDUCTED AND NO INSTANCES WERE FOUND WITHIN THESE PRODUCT LINES RELATING TO DAMAGED THREADS OR DIFFICULTY ASSEMBLING IMPLANTS. THE ROOT CAUSE OF THE SCREW BECOMING STRIPPED CANNOT BE DETERMINED WITH CONFIDENCE. STRIPPING OF THE TIBIAL FEMALE THREADS COULD BE DUE TO A VARIETY OF FACTORS: CROSS THREADING, DAMAGED THREADS, DEBRIS, OR IMPROPER LEVEL OF TORQUE BEING APPLIED IN ASSEMBLING.

    Description of Event or Problem · 1

    THE SURGEON TRIED TWO INSERTS TO SEAT IN BASEPLATE. BOTH WOULD SET BUT SCREW STRIPPED OUT OF TIBIA. THE SURGEON IMPLANTED SECOND POLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION KNEE SYSTEM TIBIAL BASEPLATE JWH 53935682

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR 392-09-608, LOT 54056701| 392-09-608, LOT 54033664