BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LCCK ARTICULAR SURFACE

    MDR report key: 1980195 · Received February 1, 2011

    Report

    Report Number
    1822565-2011-00169
    Event Type
    Injury
    Date Received
    February 1, 2011
    Date of Event
    December 28, 2010
    Report Date
    January 4, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE DEVICE WAS RETURNED WITHOUT THE LOCKING SCREW. SEVERAL FACTORS MAY LEAD TO SCREW LOOSENING: PROPER TORQUE IS NOT APPLIED ON THE SCREW DURING THE INITIAL PROCEDURE. STEM EXTENSION IS NOT PROPERLY ASSEMBLED TO THE TIBIAL PLATE. TIBIAL COMPONENT IS EXTERNALLY ROTATED WHEN IMPLANTED WHICH RESULTED IN ADDED STRESS ON THE SCREW. THE PACKAGE INSERT FOR THE DEVICE WARNS, "THE RISK OF IMPLANT FAILURE IS HIGHER WITH INACCURATE COMPONENT ALIGNMENT OR POSITIONING". HOWEVER, THERE WERE NO X-RAYS PROVIDED FOR THIS CASE TO INVESTIGATE WHETHER THIS MIGHT HAVE OCCURRED. FINALLY, COMPLICATIONS ARE POSSIBLE IF THE PT HAS INADEQUATE LIGAMENT SUPPORT. THE PACKAGE INSERT FOR THE DEVICE LISTS "SEVERE INSTABILITY SECONDARY TO THE ABSENCE OF COLLATERAL LIGAMENT INTEGRITY" AS A CONTRAINDICATION. WITHOUT ADD'L INFO, THE DEFINITIVE CAUSE OF SCREW LOOSENING CANNOT BE DETERMINED. EVAL: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECS. 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 ADD'L SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED FOR DISLOCATION, LOOSENING, AND WEAR. LOCKING SCREW IN THE POLY BACKED OUT AND WAS IN THE JOINT. POLY DISLOCATED ANTERIORLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN LCCK ARTICULAR SURFACE KNE PROSTHESIS JWH ZIMMER, INC. 60519815

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention