BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER

    MDR report key: 1020352 · Received March 27, 2008

    Report

    Report Number
    1822565-2008-00135
    Event Type
    Injury
    Date Received
    March 27, 2008
    Date of Event
    May 15, 2007
    Report Date
    February 26, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE LOOSENING MAY BE CAUSED DUE TO THE FATIGUE AND FRACTURE OF BONE CEMENT UNDER THE REPEATED LOADING AND/OR DUE TO THE WEAR DEBRIS GENERATED DUE TO THE MICRO-MOTION BETWEEN THE SHELL AND THE POLY LINER IF THE LINER IS NOT FIRMLY SECURED TO THE SHELL. NO DEFINITIVE CAUSE ANALYSIS IS POSSIBLE WITH THE INFO PROVIDED. EVAL: NO PRODUCT OR X-RAYS WERE RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND BY 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 ADD'L SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICE WAS IMPLANTED IN 1993, AND REVISED IN 2007, DUE TO LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER HIP PROSTHESIS JDI ZIMMER, INC. NA 42022300

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R