BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN STEMMED TIBIAL COMPONENT PRECOAT

    MDR report key: 1892707 · Received October 28, 2010

    Report

    Report Number
    1822565-2010-01036
    Event Type
    Injury
    Date Received
    October 28, 2010
    Date of Event
    September 29, 2010
    Report Date
    September 29, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: WITHOUT ADDITIONAL INFORMATION THE CAUSE OF THE TIBIAL PLATE LOOSENING COULD NOT BE DETERMINED. NO PRODUCT WAS RETURNED. 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, OSTEOLYSIS, AND PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN STEMMED TIBIAL COMPONENT PRECOAT KNEE PROSTHESIS JWH ZIMMER, INC. NA 52246900

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention