BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STAGEONE CEMENT SPACER MOLD

    MDR report key: 6921971 · Received October 6, 2017

    Report

    Report Number
    0001825034-2017-07563
    Event Type
    Injury
    Date Received
    October 6, 2017
    Date of Event
    May 5, 2010
    Report Date
    September 28, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWY
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED AS PART NUMBER/LOT NUMBER OF DEVICE INVOLVED IN THE INCIDENT IS UNKNOWN. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. PIGNATTI, G., NITTA, S., RANI, N., DALLARI, D., & SABBIONI, G. (2010, MAY 05). TWO STAGE HIP REVISION IN PERIPROSTHETIC INFECTION: RESULTS OF 41 CASES. THE OPEN ORTHOPAEDICS JOURNAL, 4, 193-200. DOI:10.2174/1874325001004010193.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE, A CEMENT SPACER MOLD BROKE 6 DAYS AFTER IMPLANTATION. PATIENT WAS REVISED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702912 UNKNOWN STAGEONE CEMENT SPACER MOLD PROSTHESIS, HIP KWY ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R