BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN STEMMED NONAUGMENTABLE TIBIAL

    MDR report key: 2100537 · Received May 17, 2011

    Report

    Report Number
    2648920-2011-00026
    Event Type
    Injury
    Date Received
    May 17, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 20, 2011
    Manufacturer
    ZIMMER
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. NEITHER X-RAYS NOR OPERATIVE NOTES WERE PROVIDED. AS SUCH, THE SURGICAL TECHNIQUE CANNOT BE REVIEWED AND THE IMPLANT CONSTRUCT CANNOT BE ANALYZED RADIOGRAPHICALLY. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, HEIGHT/WEIGHT, ACTIVITY LEVEL, AND TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT) ARE UNKNOWN. BASED ON THE AVAILABLE INFORMATION, AN EXACT CAUSE FOR THE REPORTED CONDITION CANNOT BE DETERMINED. 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 PATIENT UNDERWENT REVISION DUE TO SUSPECTED LOOSE TIBIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN STEMMED NONAUGMENTABLE TIBIAL JWH ZIMMER 61264015

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention