BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN STEMMED TIBIAL COMPONENT

    MDR report key: 3042107 · Received April 4, 2013

    Report

    Report Number
    2648920-2013-00091
    Event Type
    Injury
    Date Received
    April 4, 2013
    Date of Event
    March 14, 2008
    Report Date
    March 6, 2013
    Manufacturer
    ZIMMER
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF REVISION SURGICAL REPORT PROVIDED STATES THAT THE TIBIAL COMPONENT WAS LOOSE AND CAME UP READILY WITH VERY LITTLE RESECTION BEING NEEDED. NO X-RAYS WERE RECEIVED, SO NO CHECK COULD BE MADE FOR CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE 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. 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 IS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137932 NEXGEN STEMMED TIBIAL COMPONENT JWH ZIMMER 60210556

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention THE FOLLOWING DEVICES WERE MANUFACTURED BY| ZIMMER OSTEOBOND COPOLYMER DOUGH-TYPE RADIOPAQUE| BONE CEMENT| ZIMMER (B)(4)| CATALOG #00110202200, LOT # 60190119| ZIMMER DOUGH-TYPE RADIOPAQUE BONE CEMENT| CATALOG #00110100200, LOT # 60207163