BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LCCK ARTICULAR SURFACE

    MDR report key: 3031989 · Received March 28, 2013

    Report

    Report Number
    1822565-2013-00542
    Event Type
    Injury
    Date Received
    March 28, 2013
    Date of Event
    February 13, 2013
    Report Date
    March 1, 2013
    Manufacturer
    ZIMMER INC
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NO DEVICES OR PHOTOS WERE RECEIVED; THEREFORE, THE CONDITION OF THE COMPONENTS SUCH AS BONE QUALITY, ACTIVITY LEVEL OR TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT) ARE UNKNOWN. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. HOWEVER, THE COMPLAINT MAY BE REVISED UPON RETURN OF OPERATIVE REPORTS, X-RAYS AND/OR PRODUCT OR FURTHER INFORMATION. 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 RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S KNEE BECAME STRETCHED OUT AND UNSTABLE, CAUSING PAIN. THE SURGEON ELECTED TO REVISE THE KNEE AND INSERT A THICKER ARTICULAR SURFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128192 NEXGEN LCCK ARTICULAR SURFACE JWH ZIMMER INC 60658817

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention