BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALACOS BONE CEMENT 40GRAM

    MDR report key: 7040628 · Received November 17, 2017

    Report

    Report Number
    0001825034-2017-10278
    Event Type
    Injury
    Date Received
    November 17, 2017
    Date of Event
    January 24, 2017
    Report Date
    November 17, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LOD
    PMA / PMN Number
    PP810020
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL - MEDICAL PRODUCT - MAXIM POR ANA PRI FML 60 RT CATALOG# 140051 LOT# 153780 , BIOMET CC CRUCIATE TRAY 67MM CATALOG# 141232 LOT# 294670 , MAX PRI DCM TIB BRNG10X63/67MM CATALOG# 11-146130 LOT# 989460. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. 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 ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS REVISED ON THE RIGHT KNEE DUE TO LOOSENING APPROXIMATELY 16 YEARS POST-IMPLANTATION. THE COMPONENTS WERE REMOVED AND REPLACED WITH COMPETITOR PRODUCTS EXCEPT THE TIBIAL CONE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822168 PALACOS BONE CEMENT 40GRAM LOD ZIMMER BIOMET, INC. 003236 

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R