BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LCCK ARTICULAR SURFACE

    MDR report key: 2100798 · Received May 19, 2011

    Report

    Report Number
    1822565-2011-01208
    Event Type
    Injury
    Date Received
    May 19, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 21, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: POST-OPERATIVE X-RAYS REVEAL BACKING OUT OF LOCKING SCREW; HOWEVER, X-RAYS DO NOT REVEAL ANY DISLOCATION OF ART SURFACE. THERE IS ALSO NO ADDITIONAL INFO ON SURGERY/PT CHARACTERISTICS AND POST-OPERATIVE TREATMENT. IT IS UNK WHETHER THE LOCKING SCREW WAS PROPERLY INSERTED/ENGAGED INTO THE TIBIAL PLATE DURING SURGERY. UNDER-TIGHTENING OF THE LOCKING SCREW COULD RESULT IN LOOSENING OF THE SCREW PER THE SURGICAL TECHNIQUE. WITH THE AVAILABLE INFO, THE EXACT CAUSE FOR LOCKING SCREW BACKING OUT CANNOT BE DETERMINED AT THIS TIME. EVAL: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. 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 INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED FOR A LOCKING SCREW THAT HAD BACKED OUT AND POSSIBLE DISLOCATION OF THE ARTICULAR SURFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN LCCK ARTICULAR SURFACE JWH ZIMMER, INC. 41770900

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention