BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRILOGY SHELL WITH CLUSTER HOLES

    MDR report key: 2950055 · Received February 6, 2013

    Report

    Report Number
    2648920-2013-00041
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    July 13, 2010
    Report Date
    January 8, 2013
    Manufacturer
    ZIMMER
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: PRIMARY OPERATIVE NOTES WERE PROVIDED WHICH NOTE THAT THE PT HAD A VERY SHALLOW ACETABULUM AND A VERY CONGENITALLY SMALL POSTERIOR WALL. ALIGNMENT OF THE CUP WAS NOTED TO BE EXCELLENT. THE ACETABULAR CUP WAS REVISED, AND NOTED TO HAVE BEEN IN SUBSTANTIAL RETROVERSION. CAUSE CANNOT BE DEFINITIVELY DETERMINED. EVAL: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECS. 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, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED DUE TO PAIN AND A MALPOSITIONED ACETABULAR CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51145 TRILOGY SHELL WITH CLUSTER HOLES LPH ZIMMER 60514069

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention BONE SCREW: CAT #00625006535, LOT #60534220| BONE SCREW: CAT #00625006540, LOT #60505184