BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRILOGY ACETABULAR CROSSLINKED LINER

    MDR report key: 2162036 · Received July 12, 2011

    Report

    Report Number
    1822565-2011-01629
    Event Type
    Injury
    Date Received
    July 12, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 15, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: SURGICAL NOTES WERE NOT PROVIDED. X-RAYS WERE NOT PROVIDED; IT IS UNK WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. IN GENERAL, PT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS INCLUDE: AGE, BONE QUALITY, HEIGHT/WEIGHT, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS HIGH IMPACT), AND RELEVANT MEDICAL HISTORY. ADHERENCE TO REHABILITATION PROTOCOL IS UNK. THE PER INDICATED THAT THE LINER WAS IMPLANTED IN COMBINATION WITH NON-ZIMMER DEVICES WHICH IS NOT RECOMMENDED SINCE ZIMMER DEVICES HAVE NOT BEEN TESTED WITH NON-ZIMMER DEVICES. IT IS UNK IF THE USE OF NON-ZIMMER DEVICES IN COMBINATION WITH THE LINER CAUSED IT TO WEAR IN AN UNUSUAL MANNER. WITH THE INFO PROVIDED, IT IS UNK IF THE WEAR REPORTED ON THE LINER IS CONSISTENT WITH USE OVER 6 YEARS. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. THE MANUFACTURING RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING INDICATING THAT THE LINER WAS MANUFACTURED, INSPECTED, AND PACKAGED TO SPECIFICATION. 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 RECEIVED, THE COMPLAINT WILL BE RE-OPENED. ZIMMER, INC CONSIDERS THIS COMPLAINT CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED DUE TO THE ACETABULAR INSERT BEING WORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILOGY ACETABULAR CROSSLINKED LINER LPH ZIMMER, INC. 60239910

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention