BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CPT HIP SYSTEM FEMORAL STEM

    MDR report key: 1003206 · Received February 25, 2008

    Report

    Report Number
    2648920-2008-00008
    Event Type
    Malfunction
    Date Received
    February 25, 2008
    Date of Event
    January 27, 2008
    Report Date
    February 15, 2008
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    KWY
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION CODES: THE PRODUCT STATED IN THE COMPLAINT WAS NOT RETURNED FOR REVIEW. THE DEVICE HISTORY RECORDS INDICATE THE CENTRALIZER WAS PACKAGED WITH THE STEM. WITH THE GIVEN INFO, THERE IS NO DEFINITIVE AND VERIFIABLE EVIDENCE THAT THIS LOT DID NOT HAVE THE CENTRALIZER INCLUDED. HOWEVER, AS PART OF A PREVIOUS INVESTIGATION, THERE HAVE BEEN IMPROVEMENTS MADE TO FURTHER ASSURE THAT THE CENTRALIZER IS INCLUDED WITH THE STEM. THIS PARTICULAR LOT WAS MANUFACTURED PRIOR TO THESE IMPROVEMENTS.

    Description of Event or Problem · 1

    IT IS REPORTED THE DEVICE WAS PACKAGED WITHOUT A CENTRALIZER. THE DEVICE WAS IMPLANTED IN 2008, USING A SEPARATELY PACKAGED CENTRALIZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CPT HIP SYSTEM FEMORAL STEM NONE KWY ZIMMER MANUFACTURING B.V. NA 60614980

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK