BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LEGACY LCCK ARTICULAR SURFACE

    MDR report key: 2023527 · Received March 16, 2011

    Report

    Report Number
    1822565-2011-00645
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    January 11, 2011
    Report Date
    February 17, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRE-OP AND POST OP X-RAYS ARE NOT AVAILABLE TO ANALYZE THE FIXATION. SURGICAL NOTES PROVIDED INDICATE THAT THERE WAS EVIDENCE OF A COMPLETE AVULSION OF THE PATELLAR LIGAMENT AND DISRUPTION FOUND IN THE EXTENSOR MECHANISM. THE SURGEON ALSO MENTIONS THAT THE PT COULD UNDERGO FURTHER SURGICAL PROCEDURES BASED ON THE OUTCOME OF CULTURE TESTING. WITH THE AVAILABLE INFORMATION, THE PROBABLE CAUSE FOR PT'S DRAINING OF THE KNEE CANNOT BE DEFINITIVELY DETERMINED. EVALUATION: 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 INFORMATION BE REC'D, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS REVISED FOR WOUND DRAINAGE AND POSSIBLE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN LEGACY LCCK ARTICULAR SURFACE JWH ZIMMER, INC. 61632874

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention