BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 1 PC SHELL 38MMX50MM

    MDR report key: 8048211 · Received November 7, 2018

    Report

    Report Number
    0001825034-2018-10188
    Event Type
    Injury
    Date Received
    November 7, 2018
    Date of Event
    September 19, 2018
    Report Date
    April 10, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: 11-173662 ¿ M2A MODULAR HEAD ¿ 785340, X180310 ¿ BI METRIC FEMORAL STEM - 173970.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT HIP REVISION APPROXIMATELY 13 YEARS POST IMPLANTATION DUE TO METALLOSIS, ELEVATED METAL ION LEVELS, CYSTIC PSEUDOTUMORS AND TRUNNIONOSIS. DURING THE SURGERY, CENTRAL BONE LOSS IS NOTED AS WELL AS IN THE ANTERIOR WALL. CLOUDY FLUID WAS REMOVED FROM THE CAPSULE AND A SUBSTANTIAL AMOUNT OF TRUNNIONOSIS WAS NOTED WHEN THE HEAD COMPONENT WAS REMOVED. THE SURGEON ALSO NOTED THAT THE STEM WAS DIFFICULT TO REMOVE REQUIRING AN EXTENDED GREATER TROCHANTERIC OSTEOTOMY.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: UNKNOWN HEAD ¿ UNKNOWN PART AND LOT; UNKNOWN STEM ¿ UNKNOWN PART AND LOT. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 10186; 0001825034 - 2018 - 10190.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED. REPORTED EVENT WAS CONFIRMED BY REVIEW OF OPERATIVE NOTES STATING PATIENT WAS REVISED DUE TO METALLOSIS, PSEUDOTUMORS AND TRUNNIONOSIS. THE PATIENT IS NOTED TO BE EXPERIENCING ELEVATED METAL ION LEVELS, CYSTIC FORMATION AND PAIN. OSTEOLYSIS WAS FOUND AROUND THE CUP AND THE STEM ALONG WITH CLOUDY FLUID. DHR 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 PATIENT UNDERWENT A HIP REVISION DUE TO UNKNOWN REASONS AT AN UNKNOWN AMOUNT OF TIME POST INITIAL IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885998 M2A 1 PC SHELL 38MMX50MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 577050

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R