BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRILOGY CROSSLINKED POLYETHYLENE LINER

    MDR report key: 1884558 · Received October 19, 2010

    Report

    Report Number
    1822565-2010-00962
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    September 8, 2010
    Report Date
    September 8, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NO X-RAY OF THE SURGERY HAS BEEN PROVIDED. IT IS ALSO NOT KNOWN WHICH FEMORAL HEAD, SHELL AND STEM WERE IMPLANTED DURING THE PRIMARY SURGERY. THIS TYPE OF FAILURE MAY OCCUR DUE TO ONE OR COMBINATION OF THE FOLLOWING FACTORS: IMPINGEMENT, MATERIAL COMPATIBILITY BETWEEN THE LINER AND THE FEMORAL HEAD, COMPATIBILITY BETWEEN THE SHELL AND THE LINER, IMPROPER SURGICAL TECHNIQUE LEADING TO MAL-ORIENTATION OF THE COMPONENTS, IF THE LINER IS NOT LOCKED TO THE SHELL PROPERLY CAN LEAD TO BACKSIDE WEAR DUE TO MICROMOTION, HEAVY PATIENT OR HIGH PATIENT ACTIVITY, AND/OR PREVIOUS MEDICAL CONDITION. WITHOUT ADDITIONAL INFORMATION A DEFINITIVE CAUSE CANNOT BE 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 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 THE FRACTURE OF THE POLY LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILOGY CROSSLINKED POLYETHYLENE LINER HIP PROSTHESIS JDI ZIMMER, INC. 60211995

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention