BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRILOGY CROSSLINKED POLYETHYLENE LINER

    MDR report key: 2220287 · Received August 16, 2011

    Report

    Report Number
    2648920-2011-00044
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    June 14, 2011
    Report Date
    July 18, 2011
    Manufacturer
    ZIMMER
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: SURGICAL NOTES WERE PROVIDED FROM THE PRIMARY AND REVISION SURGERY. NO COMPLICATIONS WERE NOTED IN THE PRIMARY NOTES. THE COMPONENTS WERE NOTED AS WELL-FIXED. IT WAS NOTED IN THE REVISION NOTES THAT THERE WAS AN INCOMPLETE REPAIR OF THE POSTERIOR CAPSULE. THIS DEFICIENCY MAY HAVE BEEN A SOURCE OF THE INSTABILITY. X-RAYS WERE NOT PROVIDED; IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. DURING THE REVISION, IT WAS NOTED THAT THE REPLACEMENT SHELL WAS POSITIONED MORE HORIZONTAL AND WITH LESS ANTEVERSION; WHICH MAY INDICATE THAT THE SURGEON FELT THE REVISED SHELL WAS NOT IN AN IDEAL ORIENTATION FOR THE PATIENT. TAKING THE ABOVE INFORMATION INTO CONSIDERATION, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. EVALUATION: 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 INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO INSTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILOGY CROSSLINKED POLYETHYLENE LINER LPH ZIMMER 60701676

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention