BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STAGEONE CEMENT SPACER

    MDR report key: 6922095 · Received October 6, 2017

    Report

    Report Number
    0001825034-2017-07706
    Event Type
    Injury
    Date Received
    October 6, 2017
    Date of Event
    May 5, 2010
    Report Date
    October 7, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBB
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    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 IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORT EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. 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 (B)(4) CASES. THE OPEN ORTHOPAEDICS JOURNAL,, 4, 193-200. DOI:10.2174/1874325001004010193 - (B)(4).

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS THIS COMPONENT IS COMPETITOR PRODUCT. THE INITIAL REPORT SHOULD BE VOIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE, ONE PATIENT EXPERIENCED POST-OPERATIVE ARTERIAL BLEEDING (AFTER SECOND STAGE OPERATION), THAT WAS TREATED WITH EMBOLIZATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703584 UNKNOWN STAGEONE CEMENT SPACER PROSTHESIS, HIP MBB ZIMMER BIOMET, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R