BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN STEMMED TIBIAL COMPONENT

    MDR report key: 1924224 · Received December 7, 2010

    Report

    Report Number
    1822565-2010-01273
    Event Type
    Injury
    Date Received
    December 7, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 10, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 REVISION SURGERY OCCURRED APPROX SIX YEARS AFTER IMPLANTATION. X-RAYS WERE NOT RETURNED FOR ANALYSIS. WITHOUT ADD'L INFO, THE CAUSE OF FAILURE COULD NOT BE DETERMINED. EVAL: REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. 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 AVAILABLE INFO, 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 PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIAL BASEPLATE AND OSTEOLYSIS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention