BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODULAR LATERALIZED TAPERLOC FEMORAL POROUS COATED STEM

    MDR report key: 7785598 · Received August 15, 2018

    Report

    Report Number
    0001825034-2018-04745
    Event Type
    Injury
    Date Received
    August 15, 2018
    Date of Event
    June 23, 2015
    Report Date
    March 19, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K030055
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF THE LEGAL NOTES. THE LEGAL DOCUMENTS NOTED A PSEUDOCAPSULE, BROWNISH GRAY DEBRIS CONSISTENT WITH METAL REACTION,THE FEMORAL NECK AT THE TRUNNION WAS DISCOLORED BUT NOT PALPABLY ROUGH AND THE INNER PORTION OF THE MORSE TAPER OF THE FEMORAL HEAD WAS LIKEWISE DISCOLORED AND AT THE MARGIN OF THE FEMORAL HEAD, NOT IN THE MORSE TAPER ITSELF, THERE WAS SOME CORROSION THAT ACCUMULATED ON THE FEMORAL HEAD. 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 · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY 6 YEARS POST INITIAL SURGERY DUE TO ELEVATED METAL IONS IN BLOOD, TISSUE AND BONE SURROUNDINGS, PAIN, DISCOMFORT AND INFLAMMATION. DURING THE SURGERY, THE SURGEON FOUND BROWNISH GRAY DEBRIS CONSISTENT WITH METAL REACTION. THE FEMORAL NECK AT THE TRUNNION WAS DISCOLORED BUT NOT PALPABLY ROUGH. THE INNER PORTION OF THE MORSE TAPER OF THE FEMORAL HEAD WAS LIKEWISE DISCOLORED AND AT THE MARGIN OF THE FEMORAL HEAD, NOT IN THE MORSE TAPER ITSELF, THERE WAS SOME CORROSION THAT ACCUMULATED ON THE FEMORAL HEAD.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). UNIQUE IDENTIFIER (UDI) #: N/A. CONCOMITANT MEDICAL PRODUCTS: MAGNUM MODUAR HEAD, # ITEM S061140, LOT 757570. TAPERLOC FEMORAL INSERT, # ITEM 159436, LOT 961580. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-04746. IT IS UNKNOWN IF PRODUCT WILL BE RETURNING TO ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY 6 YEARS POST INITIAL SURGERY DUE TO ELEVATED METAL IONS IN BLOOD, TISSUE AND BONE SURROUNDINGS, PAIN, DISCOMFORT AND INFLAMMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627655 MODULAR LATERALIZED TAPERLOC FEMORAL POROUS COATED STEM PROSTHESIS HIP LPH ZIMMER BIOMET, INC. 961580

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R