BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN MIS STEMMED TIBIAL COMPONENT

    MDR report key: 2010508 · Received March 1, 2011

    Report

    Report Number
    1822565-2011-00451
    Event Type
    Injury
    Date Received
    March 1, 2011
    Date of Event
    January 24, 2011
    Report Date
    January 31, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE PRIMARY TKA WAS UNCOMPLICATED, AND THERE WAS NO POST-OP INFECTION. NO PRODUCTS WERE RETURNED FOR EXAMINATION. THE RETURNED X-RAYS SHOW THAT THE TIBIA HAD SUBSIDED MEDICALLY AND THE TIBIA HAD FRACTURED MID-SHAFT DUE TO THE STRESSES OF THE TIBIAL SUBSIDENCE. WITHOUT ADD'L INFO, AN EXACT CAUSE CANNOT BE DETERMINED. EVAL: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED DUE TO MEDIAL SUBSIDENCE OF THE BASEPLATE AND A MIDSHAFT TIBIA FRACTURE DUE TO STRESSES OF TIBIAL SUBSIDENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN MIS STEMMED TIBIAL COMPONENT JWH ZIMMER, INC. 60790428

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention