BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC POR FMRL 15X150

    MDR report key: 8548950 · Received April 25, 2019

    Report

    Report Number
    0001825034-2019-01870
    Event Type
    Injury
    Date Received
    April 25, 2019
    Date of Event
    April 4, 2018
    Report Date
    April 25, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K030055
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS - BIOMET M2A TAPER ADAPTER CATALOG#: 139264 LOT#: 545160; M2A-MAGNUM MOD HD # ITEM 157454 LOT 044670; M2A-MAGNUM PF CUP 60ODX54ID # ITEM US157860 LOT 063400. REPORTED EVENT WAS CONFIRMED BY REVIEW OF REVISION OP NOTES. RIGHT REVISION OP DEMONSTRATED THAT THE PATIENT WAS REVISED DUE TO METALLOSIS. UPON ENTERING THE JOINT, THERE WAS SOME CLEAR FLUID THERE, NOTHING TOO REMARKABLE. THERE IS A LOT OF CASEOUS MATERIAL IN THERE, AND THAT WAS DEBRIDED. THERE WAS A SHINY LINING OF THE HIP JOINT OF SOME ACELLULAR TYPE MATERIAL THAT WAS DEBRIDED. THERE WAS NO REAL METAL STAINED-TYPE AREAS. HEAD WAS REMOVED AND THERE WAS A MINIMAL TO MODERATE AMOUNT OF CORROSION WITH JUST SOME OXIDATION-TYPE MATERIAL VISIBLE ON THE TRUNNION. NEW HEAD AND BEARING WERE IMPLANTED AND HIP WAS REDUCED AND FOUND STABLE. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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 WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT HIP REVISION 12 YEARS POST INITIAL SURGERY DUE TO METALLOSIS AND ELEVATED METAL ION LEVELS. DURING THE REVISION, CASEOUS MATERIAL AND MINIMAL CORROSION ON THE TRUNNION WERE NOTED. THE FEMORAL HEAD WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344547 TAPERLOC POR FMRL 15X150 PROSTHESIS HIP LPH ZIMMER BIOMET, INC. N/A 483100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other