BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRILOGY LONGEVITY POLY LINER

    MDR report key: 2940735 · Received January 31, 2013

    Report

    Report Number
    1822565-2013-00201
    Event Type
    Injury
    Date Received
    January 31, 2013
    Date of Event
    February 12, 2011
    Report Date
    January 2, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: HOSPITAL NOTES STATE THAT THE PT WAS STARTED ON A REGIMEN OF VANCOMYCIN AND A CLOSED TUBE SYSTEM WAS PLACED AFTER THE I & D. DRAINAGE LATER TURNED OUT TO BE (B)(6). THE SIMMER STERILIZATION VENDOR PROCESSES ALL IMPLANTS TO MEET FDA REGULATION AND ISO STANDARDS AT A STERILITY ASSURANCE LEVEL (SAL) OF 1.0 X 10-6 OR BETTER. THEREFORE, IT IS HIGHLY UNLIKELY THAT HE SPECIFIED DEVICE CAUSED OR CONTRIBUTED TO ANY PT INFECTION. 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 AND EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT BEGAN EXPERIENCING PAIN. ON (B)(6) 2011, THE PT UNDERWENT AN ASPIRATION. THE CULTURE WAS (B)(6) FOR (B)(6), SO ON (B)(6) 2011, THE PT UNDERWENT AN IRRIGATION AND DEBRIDEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43121 TRILOGY LONGEVITY POLY LINER LPH ZIMMER, INC. 55915100

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention VERSYS FEMORAL HEAD,| CABLE-READY CERCLAGE CABLE W/ CRIMPS,| VERSYS FEMORAL STEM,| TRILOGY SHELL WITH CLUSTER HOLES,| BONE SCREW, CAT #00625006525, LOT #26839500| CAT #00620005222, LOT #25074201| CAT #00784101400, LOT #54924500| CAT #00223200118, LOT #53241000| CAT #00801802801, LOT #26230000| BONE SCREW, CAT #00625006530, LOT #26536200