BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRILOGY LONGEVITY CROSSLINKED POLY LINER

    MDR report key: 1901435 · Received November 11, 2010

    Report

    Report Number
    1822565-2010-01113
    Event Type
    Injury
    Date Received
    November 11, 2010
    Date of Event
    October 11, 2010
    Report Date
    October 15, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A HEALTH PROFESSIONAL WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: THE DEVICE WAS IN VIVO FOR APPROXIMATELY 15 DAYS. NO X-RAYS WERE PROVIDED. OPERATIVE INFORMATION FROM THE PRIMARY AND REVISION SURGERY WAS PROVIDED. IT IS UNKNOWN IF THE DEVICES WERE IMPLANTED WITH THE CORRECT ORIENTATION AND FIT AS PER THE SURGICAL TECHNIQUE. THE MATING INSTRUMENTATION USED DURING SURGERY IS UNKNOWN. POSSIBLE CAUSES FOR DISLOCATION AND INSTABILITY INCLUDE ONE OR MORE OF THE FOLLOWING: IMPROPER SHELL SIZE SELECTED, INCORRECT COMPONENT POSITIONING, FEMORAL COMPONENT IMPINGEMENT, PATIENT ANATOMY PRONE TO DISLOCATION, SOFT TISSUE IMBALANCE, JOINT LAXITY, PATIENT BEHAVIOR. WITH THE INFORMATION PROVIDED, THE EXACT CAUSE DISLOCATION CANNOT BE DETERMINED WITH CERTAINTY. 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 DISLOCATION AND INSTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILOGY LONGEVITY CROSSLINKED POLY LINER HIP PROSTHESIS JDI ZIMMER, INC. 60866437

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention