BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M/G PRECOAT UNICOMPARTMENTAL TIBIAL PLATE

    MDR report key: 2082937 · Received May 3, 2011

    Report

    Report Number
    1822565-2011-01105
    Event Type
    Injury
    Date Received
    May 3, 2011
    Date of Event
    March 29, 2011
    Report Date
    April 4, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: THE EXPLANTS WERE NOT RETURNED FOR REVIEW. NEITHER X-RAYS NOR OPERATIVE NOTES WERE PROVIDED. AS SUCH, THE IMPLANT CONSTRUCT CANNOT BE EXAMINED RADIOGRAPHICALLY AND THE SURGICAL TECHNIQUE CANNOT BE REVIEWED. BASED ON THE AVAILABLE INFO, A CAUSE FOR THE REPORTED CONDITION CANNOT BE DETERMINED. SHOULD ADD'L SUBSTANTIVE INFO REGARDING THE CASE BE RECEIVED SUBSEQUENT TO COMPLAINT CLOSURE, THE COMPLAINT WILL BE REOPENED AND REPROCESSED. 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. 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 WAS REVISED FOR PAIN. X-RAYS SHOWED THE TIBIAL COMPONENT HAD SHIFTED INTO A VARUS POSITION AND THERE WAS SIGNIFICANT POLY WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M/G PRECOAT UNICOMPARTMENTAL TIBIAL PLATE HSX ZIMMER, INC. 60023594

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention