BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURAL-HIP TAPER STEM

    MDR report key: 3201693 · Received June 28, 2013

    Report

    Report Number
    1822565-2013-01043
    Event Type
    Injury
    Date Received
    June 28, 2013
    Date of Event
    September 14, 2006
    Report Date
    May 31, 2013
    Manufacturer
    ZIMMER INC
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ZIMMER STERILIZATION VENDOR PROCESSES ALL IMPLANTS TO MEET FDA REGULATIONS AND ISO STANDARDS AT A STERILITY ASSURANCE LEVEL (SAL) OF 1.0 X 10-6 OR BETTER. THEREFORE, IT IS HIGHLY UNLIKELY THAT THE SPECIFIED DEVICE CAUSED OR CONTRIBUTED TO ANY PT INFECTION. CAUSED CANNOT BE DEFINITIVELY DETERMINED. EVAL CODES: 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 ADD'L SUBSTANTIVE INFO 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 PT UNDERWENT AND I&D ON (B)(6) 2006 AND THEN UNDERWENT A 2 STAGE REVISION FOR INFECTION. THE FIRST STAGE OCCURRED ON (B)(6) 2006 AND FINAL COMPONENTS WERE IMPLANTED ON (B)(6) 2006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296714 NATURAL-HIP TAPER STEM LPH ZIMMER INC 1434144

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention