BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY LONGEVITY POLYETHYLENE LINER

    MDR report key: 1932178 · Received December 14, 2010

    Report

    Report Number
    1822565-2010-01338
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Report Date
    November 16, 2010
    Manufacturer
    ZIMMER
    Product Code
    JDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: WITH THE INFORMATION PROVIDED, THE MOST PROBABLE CAUSE FOR THE PT'S PAIN IS THE REPORTED LEG LENGTH DISCREPANCY REPORTED BY THE PT. THIS INDICATES THE MOST LIKELY AT THE TIME OF IMPLANTATION, AN UNSATISFACTORY RECONSTRUCTION OF THE PT'S NATURAL OFFSET, VERSION AND LEG LENGTH WAS CREATED WITH THE PROSTHESES. ZIMMER OFFERS A VARIETY OF OPTIONS WITH THESE PRODUCTS TO APPROPRIATELY REPRODUCE THE NATURAL HIP JOINT STRUCTURE WHICH IS COVERED IN THE CORRESPONDING SURGICAL TECHNIQUES. WITH AVAILABLE INFORMATION, A DEFINITIVE CAUSE CANNOT BE DETERMINED. 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.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICES WERE IMPLANTED IN 2009 AND THE PT IS UNABLE TO LIFT HER LEG; SHE IS IN SEVERE PAIN, CAN'T SIT, WALK OR WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILOGY LONGEVITY POLYETHYLENE LINER HIP PROSTHESIS JDI ZIMMER 61044370

    Patients

    Seq Age Sex Outcome Treatment
    1 LOT #61083469| CATALOG # 00620005022, LOT #60036774| CATALOG #65786201100, LOT #61006310| VERSYS HIP SYSTEM FEMORAL STEM| SYSTEM FEMORAL HEAD, CATALOG #00801803203| TRILOGY ACETABULAR SYSTEM SHELL WITH CLUSTER HOLES