BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN STEMMED TIBIAL COMPONENT

    MDR report key: 3012278 · Received March 12, 2013

    Report

    Report Number
    2648920-2013-00070
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    January 29, 2013
    Report Date
    February 11, 2013
    Manufacturer
    ZIMMER
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SURGICAL REPORTS WERE NOT PROVIDED; THEREFORE, WHETHER RECOMMENDED SURGICAL TECHNIQUE WAS FOLLOWED IS UNK. PT 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 UNK. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. HOWEVER, THE COMPLAINT MAY BE REVISED UPON RETURN OF OPERATIVE REPORTS OR FURTHER INFORMATION. AS RETURNED, THE MEASURED DIMENSIONS OF THE TIBIAL PLATE WERE FOUND TO BE WITHIN SPECIFICATION. NO BONE CEMENT RESIDUE WAS OBSERVED ON THE TIBIAL PLATE. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED DIE TO PAIN AND LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104743 NEXGEN STEMMED TIBIAL COMPONENT JWH ZIMMER 60865956

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention