BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTINUUM TRILOGY IT LONGEVITY POLY LINER

    MDR report key: 2080184 · Received April 7, 2011

    Report

    Report Number
    1822565-2011-00887
    Event Type
    Malfunction
    Date Received
    April 7, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 11, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: THE CONTINUUM SHELL AND ELEVATED LINER REMAIN IMPLANTED. THE RETURNED NEUTRAL LINER WAS DIMENSIONALLY ANALYZED AND FOUND TO BE WITHIN SPECIFICATIONS WHERE MEASURED. AS THE SHELL AND ELEVATED LINER REMAIN IMPLANTED, THEIR CONDITION AT THE TIME OF THE ALLEGED EXPERIENCE IS UNKNOWN. THE RETURNED LINER APPEARS PRISTINE WITH NO VISIBLE DAMAGE. THE ATTEMPT TO REPRODUCE THE ALLEGED EXPERIENCE WITH THE RETURNED LINER WAS UNSUCCESSFUL, AND NO PROBLEM WAS FOUND WITH ITS INTENDED FUNCTION. GIVEN THE INFORMATION PROVIDED AND THE ANALYSIS PERFORMED, A DEFINITIVE CAUSE FOR THE REPORTED EXPERIENCE 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. 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 LINER WOULD NOT SEAT AND THE NEUTRAL LINER WAS SELECTED AS A SECOND OPTION. AFTER NEITHER LINER WOULD SEAT, THE ELEVATED LINER WAS CHILLED ON ICE AND FINALLY IMPACTED INTO POSITION. THIS INCIDENT ADDED 1 HOUR TO SURGICAL TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTINUUM TRILOGY IT LONGEVITY POLY LINER JDI ZIMMER, INC. 61380279

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR LONGEVITY HIGHLY CROSSLINKED POLYETHYLENE LINER| LOT #61372445| CONTINUUM ACETABULAR SYSTEM TRABECULAR METAL SHELL| CONTINUUM TRILOGY IT ALLOFIT IT ACETABULAR SYSTEMS| WITH MULTI HOLES POROUS: CATALOG #00875704402| ELEVATED RIM: CATALOG #00875200628, LOT #61412831