BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRILOGY ACETABULAR SYSTEM LINER

    MDR report key: 1060445 · Received June 13, 2008

    Report

    Report Number
    1822565-2008-00312
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    February 12, 2007
    Report Date
    May 16, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS IN-VIVO FOR APPROXIMATELY 137 MONTHS. DEVICES AND POST SURGERY X-RAYS ARE NOT AVAILABLE FOR REVIEW. SURGERY DETAILS OF HOW THE LINER WAS ASSEMBLED ARE NOT AVAILABLE. LINER WEAR PERFORMANCE/DEGRADATION OF A COMPONENT IS DEPENDENT ON MANY FACTORS, INCLUDING PT ACTIVITY AND PT WEIGHT, MANY OF WHICH ARE OUT OF THE CONTROL OF THE MFR. THE COMPONENT IN QUESTION WAS PROPERLY MANUFACTURED FROM APPROVED MATERIALS IN ACCORDANCE WITH THE MANUFACTURING PRACTICES OF THE TIME. DETAILS LIKE BODY WEIGHT DURING IMPLANT AND EXPLANT, ACTIVITY LEVEL, BUILD, AND SEX ARE NOT AVAILABLE FOR CURRENT CASE. SINCE THE POLY-LINER WAS NOT SENT FOR REVIEW, IN-HOUSE STUDY COULD NOT BE PERFORMED. CAUSE CANNOT BE DEFINITIVELY DETERMINED. NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY 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 ADDITIONAL SUBSTANTIVE INFO BE REC'D, 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 1995. THE DEVICE WAS REVISED IN 2007, DUE TO DISLOCATION, LINER WEAR, AND MILD ACETABULAR OSTEOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILOGY ACETABULAR SYSTEM LINER HIP PROSTHESIS KWB ZIMMER, INC. NA 52167200

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R