BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY LONGEVITY CROSSLINKED POLY LINER

    MDR report key: 1932200 · Received December 14, 2010

    Report

    Report Number
    1822565-2010-01341
    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 Location
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A CONSUMER WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: SURGICAL NOTES INDICATE THAT ZIMMER TRABECULAR METAL SHELL AND LONGEVITY LINER WERE USED IN COMBINATION WITH A STRYKER FEMORAL HEAD AND STEM. IT IS UNK IF THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION PER THE SURGICAL TECHNIQUE. THE CONDITION OF THE IMPLANTS IS UNK. THE INSTRUMENTATION USED IN THE SURGERY IS UNK. IT IS ALSO UNK IF THE PT FOLLOWED THE PROPER REHABILITATION PROTOCOLS. IN ADDITION, THE PACKAGE INSERT STATES THAT ONLY AUTHORIZED COMBINATIONS OF IMPLANTS SHOULD BE USED. NO STRYKER IMPLANTS ARE IDENTIFIED AS COMPATIBLE WITH ZIMMER IMPLANTS. BASED ON THE INFO PROVIDED, IT IS NOT POSSIBLE TO DETERMINE A CAUSE FOR THIS ISSUE WITH CERTAINTY. EVAL: 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 INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT IS PRESENTING WITH PAIN AND MUSCLE WEAKNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILOGY LONGEVITY CROSSLINKED POLY LINER HIP PROSTHESIS JDI ZIMMER 61358739

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR (B)(4)| TRABECULAR METAL MODULAR ACETABULAR SHELL,| CAT # 00620204822, LOT # 60529513 -