BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL HIP SYSTEM ACETABULAR LINER STANDARD

    MDR report key: 1030157 · Received April 16, 2008

    Report

    Report Number
    1822565-2008-00180
    Event Type
    Injury
    Date Received
    April 16, 2008
    Date of Event
    March 12, 2008
    Report Date
    March 18, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWB
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: DEVICES AND X-RAYS WERE NOT AVAILABLE FOR REVIEW. PT DETAILS LIKE BUILD, WEIGHT, ACTIVITY LEVEL AND SEX ARE NOT AVAILABLE. NO ENGINEERING ANALYSIS COULD BE DONE WITH AVAILABLE INFO. DEVICE WAS IN-VIVO FOR APPROX 12 YRS. CAUSE CANNOT BE DEFINITIVELY DETERMINED. EVALUATION: NO PROD WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PROD FAILED TO MEET SPECS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PROD 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 1996. WEAR IN LINER WAS INDICATED FROM X-RAYS. REVISION SURGERY TO REPLACE LINER OCCURRED IN 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL HIP SYSTEM ACETABULAR LINER STANDARD HIP PROSTHESIS KWB ZIMMER, INC. NA 49158100

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R