BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN LCCK ARTICULAR SURFACE

    MDR report key: 2042302 · Received February 15, 2011

    Report

    Report Number
    1822565-2011-00603
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    February 14, 2011
    Report Date
    February 16, 2011
    Manufacturer
    ZIMMER INC
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: SURGICAL NOTES WERE NOT PROVIDED. X-RAYS WERE NOT PROVIDED; IT IS UNK WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. THERE IS INSUFFICIENT INFORMATION TO PERFORM A PROBABLE CAUSE ANALYSIS. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE LOT NUMBER REQUIRED FOR RETRIEVAL IS UNAVAILABLE. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE AVAILABLE INFORMATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT WHILE REMOVING POLY SCREW WITH THE TENSIONER, SCREW BROKE AT THE JUNCTION AND SCREW SHAFT AND PART OF SCREW THREADS WERE LEFT IN THE TIBIAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN LCCK ARTICULAR SURFACE JWH ZIMMER INC

    Patients

    Seq Age Sex Outcome Treatment
    1