BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER ALUMINA CERAMIC FEMORAL HEAD

    MDR report key: 5520258 · Received March 23, 2016

    Report

    Report Number
    1822565-2016-00735
    Event Type
    Injury
    Date Received
    March 23, 2016
    Report Date
    February 29, 2016
    Manufacturer
    ZIMMER INC
    Product Code
    MRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). OTHER DEVICE USED: CATALOG #00631005628, TRILOGY LONGEVITY LINER, LOT #60268046; CATALOG #00771101120, ZIMMER M/L TAPER FEMORAL STEM, LOT #60201839; CATALOG #00620005622, TRILOGY SHELL WITH CLUSTER HOLES, LOT #60295143 MANUFACTURED BY ZIMMER B.V. (B)(4). THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    NO DEVICES OR PHOTOS WERE RECEIVED, THEREFORE THE CONDITION OF THE DEVICES IS UNKNOWN. DEVICE HISTORY RECORD REVIEW IDENTIFIED NO DEVIATIONS OR ANOMALIES IN THE MANUFACTURING PROCESS. THESE DEVICES ARE USED FOR TREATMENT. THE DEVICES WERE USED IN AN APPROVED AND COMPATIBLE COMBINATION. RELEVANT MEDICAL HISTORY AND ADHERENCE TO REHABILITATION PROTOCOL ARE UNKNOWN. OPERATIVE NOTES FOR PROCEDURE PERFORMED ON (B)(6) 2005 WERE REVIEWED. IT IS NOTED THAT THE ACETABULAR CUP HAD GOOD PRESS FIT WITH ONE SCREW FIXATION. REDUCTION WITH THE FINAL COMPONENTS NOTED THAT THE STABILITY WAS EXCELLENT. LEG LENGTHS WERE NOTED TO BE EQUAL. IT IS NOTED THAT THERE WERE NO COMPLICATIONS. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Description of Event or Problem · 1

    IT IS REPORTED THE PATIENT IS ALLEGING HARM CAUSED BY THE DEVICE, HOWEVER THE NATURE OF THE HARM IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175587 ZIMMER ALUMINA CERAMIC FEMORAL HEAD MRA MRA ZIMMER INC 60289025

    Patients

    Seq Age Sex Outcome Treatment
    1 Other