BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REFOBACIN BONE CEMENT R 40X2 GERMAN

    MDR report key: 5242609 · Received November 23, 2015

    Report

    Report Number
    3002806535-2015-04082
    Event Type
    Injury
    Date Received
    November 23, 2015
    Report Date
    October 29, 2015
    Manufacturer
    BIOMET FRANCE S.A.R.L
    Product Code
    LOD
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS USER FACILITY IS OUTSIDE OF THE UNITED STATES. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN (B)(4) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K051496.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON (B)(6) 2014. A COMPETITOR KNEE IMPLANT AND ZIMMER BIOMET CEMENT WERE IMPLANTED. SUBSEQUENTLY, PATIENT ALLEGES AN ALLERGIC REACTION. HOWEVER, NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773444 REFOBACIN BONE CEMENT R 40X2 GERMAN BONE CEMENT LOD BIOMET FRANCE S.A.R.L N/A A142BB0406

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention