BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZMR HIP SYSTEM FEMORAL STEM REVISION TAPER

    MDR report key: 1030153 · Received April 16, 2008

    Report

    Report Number
    1822565-2008-00183
    Event Type
    Injury
    Date Received
    April 16, 2008
    Date of Event
    February 6, 2008
    Report Date
    March 17, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION - THE TAPER STEM HAS FRACTURED AT THE JUNCTION WITH THE TAPER BODY. SCANNING ELECTRON MICROSCOPY ANALYSIS SHOWS THAT THE FRACTURE HAS OCCURRED BY FATIGUE. THE PACKAGE INSERT CONTAINS STATEMENTS WARNING THAT DEVICE FRACTURES MAY OCCUR WHERE EXCESSIVE PT WEIGHT, EXCESSIVE PT ACTIVITY, OR LACK OR PROXIMAL SUPPORT OF THE BODY ARE INVOLVED. NOT ALL OF THESE FACTORS ARE KNOWN FOR THIS CASE. THERE IS NO DEFINITIVE INDICATION THAT DESIGN OR MANUFACTURE OF THE DEVICE CONTRIBUTED TO THE OUTCOME DESCRIBED HERE. RISK MANAGEMENT ACTIVITY HAS BEEN INITIATED. SHOULD ADDITIONAL SUBSTANTIVE INFO BE RECEIVED, THIS REPORT WILL BE AMENDED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICES WERE IMPLANTED IN 2002. THE DEVICES WERE DISCOVERED TO BE FRACTURED IN 2008. REVISION SURGERY OCCURRED TWO WEEKS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZMR HIP SYSTEM FEMORAL STEM REVISION TAPER HIP PROSTHESIS KWY ZIMMER, INC. NA 73866500

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R REVISION TAPER| CATALOG #00999207545 ZMR HIP SYSTEM FEMORAL BODY