BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER M/L TAPER MODULAR FEMORAL STEM

    MDR report key: 2130678 · Received June 14, 2011

    Report

    Report Number
    1822565-2011-01373
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    May 5, 2011
    Report Date
    May 16, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS REC'D FROM A HEALTH PROFESSIONAL WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: THE STERILIZATION PROCESS FOR ALL DEVICES PRODUCED AT ZIMMER ARE VALIDATED IN ACCORDANCE WITH FDA REGULATIONS AND ISO STANDARDS TO A STERILITY ASSURANCE LEVEL (SAL) OF 1.0 X 10 (-6) OR BETTER, AND ARE PROCESSED ACCORDING TO THE VALIDATED STERILIZATION PROCESS PARAMETERS AND MUST MEET ALL THE ACCEPTANCE CRITERIA BEFORE STERILITY RELEASE. THEREFORE, IT IS HIGHLY UNLIKELY THAT THE SPECIFIED DEVICE CAUSED OR CONTRIBUTED TO ANY PT INFECTION. 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. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE REC'D, 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 INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER M/L TAPER MODULAR FEMORAL STEM LPH ZIMMER, INC. 61359852

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention CATALOG #00630505840, LOT #61347746| TRILOGY LONGEVITY CROSSLINKED POLYETHYLENE LINER| (B)(4)| TRILOGY SHELL WITH CLUSTER HOLES,| KINECTIV TECHNOLOGY MODULAR NECK,| CATALOG #00620005822, LOT #61350542| (B)(4)| VERSYS FEMORAL HEAD, CATALOG #00801804002,| CATALOG #00784802400, LOT #61450118| LOT #61459423 - (B)(4)