BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER UNICOMPARTMENTAL TIBIAL COMPONENT

    MDR report key: 2343557 · Received November 15, 2011

    Report

    Report Number
    1822565-2011-02529
    Event Type
    Injury
    Date Received
    November 15, 2011
    Date of Event
    October 17, 2011
    Report Date
    October 18, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: PHOTOGRAPHS AND X-RAYS WERE NOT PROVIDED; THEREFORE, IT IS UNK WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AND WHAT CONDITION THEY ARE IN. SURGICAL NOTES WERE REVIEWED AND DID NOT INDICATE A ROOT CAUSE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFO PROVIDED. EVAL: AS THE PRODUCT HAS NOT BEEN RECEIVED, A REVIEW OF THE DEVICE COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING; INDICATING THE DEVICE WAS MANUFACTURED, INSPECTED, AND PACKAGED TO SPECIFICATION. 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 ADD'L SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC., CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT HAS BEEN REVISED DUE TO LOOSENING OF THE TIBIAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER UNICOMPARTMENTAL TIBIAL COMPONENT HSX ZIMMER, INC. 60662675

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention