BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER TRILOGY SHELL

    MDR report key: 2921471 · Received January 9, 2013

    Report

    Report Number
    1822565-2013-00045
    Event Type
    Injury
    Date Received
    January 9, 2013
    Report Date
    December 10, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A FOREIGN SOURCE WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: NEITHER X-RAYS NOR SURGICAL NOTES ARE PROVIDED FOR REVIEW; IT IS UNK IF THE DEVICES WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. PT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS AGE, BONE QUALITY, HEIGHT/WEIGHT, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS HIGH IMPACT), AND RELEVANT MEDICAL HISTORY ARE UNKNOWN. REHABILITATION PROTOCOL AND ADVERSE THERETO IS UNK. WITH THE INFO PROVIDED, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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 RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTING THAT THE PT WAS REVISED DUE TO THE CUP LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12617 UNKNOWN ZIMMER TRILOGY SHELL HIP PROSTHESIS LPH ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention