BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSYS HIP FEMORAL STEM BEADED FULLCOAT

    MDR report key: 1892214 · Received October 26, 2010

    Report

    Report Number
    1822565-2010-00982
    Event Type
    Injury
    Date Received
    October 26, 2010
    Date of Event
    June 17, 2010
    Report Date
    September 27, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE STERILIZATION PROCESS FOR THESE DEVICES WERE VALIDATED IN ACCORDANCE WITH FDA REGULATIONS AND ISO STANDARDS TO A STERILITY ASSURANCE LEVEL (SAL) OF 1.0 X 10 (-6) OR BETTER. THE MFG LOTS SPECIFIED IN THIS COMPLAINT WERE PROCESSED ACCORDING TO THE VALIDATED STERILIZATION PROCESS PARAMETERS AND MET ALL THE ACCEPTANCE CRITERIA FOR STERILITY RELEASE. THEREFORE, IT IS HIGHLY UNLIKELY THAT THE SPECIFIED DEVICES CAUSED OR CONTRIBUTED TO ANY PT INFECTION. NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEEDED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADD'L SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSYS HIP FEMORAL STEM BEADED FULLCOAT HIP PROSTHESIS KWY ZIMMER, INC. 61127265

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention TM MODULAR ACETABULAR SHELL WITH CLUSTER HOLES-| POLYETHYLENE LINER, CATALOG# 00630506440,| LOT# 61469170, (MFG BY ZIMMER B.V.)| TRILOGY ACETABULAR LONGEVITY CROSSLINKED| VERSYS FEMORAL HEAD TAPER, CATALOG# 00801804001| LOT# 61068584| POROUS, CATALOG # 00620206422, LOT# 60862346