BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HEAD

    MDR report key: 8800955 · Received July 17, 2019

    Report

    Report Number
    0001825034-2019-02996
    Event Type
    Injury
    Date Received
    July 17, 2019
    Date of Event
    March 7, 2018
    Report Date
    August 29, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. REVISION OP NOTE DEMONSTRATED THAT THE PATIENT WAS REVISED DUE TO METALLOSIS. EXTERNAL ROTATORS WERE DETACHED FROM THE GREATER TROCHANTER. METAL WEAR DEBRIS SYNOVITIS WAS FOUND OVER THE GREATER TROCHANTER. TRIAL TO REMOVE MAGNUM HEAD WITH AN OFFSET IMPACTOR FAILED D/T COLD WELD OF NECK ADAPTER INTO STEM TRUNNION. MIDAS REX CARBIDE WHEEL USED TO SEPARATE HEAD FROM NECK ADAPTOR. ONCE APPROPRIATE CLEARING OF METAL ACHIEVED, OSTEOTOME INSERTED AND BY VIBRATION, COLD WELD WAS SEPARATED AND HEAD EASILY REMOVED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: PART: US157860, M2A-MAGNUM PF CUP 60ODX54ID, LOT: 193170, PART: 157454, M2A-MAGNUM MOD HD SZ 54MM, LOT: 630530, PART: 139264, M2A-MAGNUM 52-60MM TPR INSRT-6, LOT: 134520, PART: X12-171314, INTEGRAL/X POR RED PROX 14MM, LOT: 401630, PART: 800-1003A, GPS 111 SINGLE KIT, LOT: 006390. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: CUP: 0001825034-2019-02995, HEAD: 0001825034-2019-02996, TAPER: 0001825034-2019-02998, STEM: 0001825034-2019-02999.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY, SUBSEQUENTLY THE PATIENT UNDERWENT A REVISION PROCEDURE NINE YEARS LATER DUE TO PATIENT ALLEGATIONS OF METAL WEAR DEBRIS SYNOVITIS WAS FOUND THROUGHOUT THE JOINT SPACE. PATIENT'S OPERATIVE REPORTS INDICATED THAT THE EXTERNAL ROTATORS WERE DETACHED FROM THE GREATER TROCHANTER. FURTHER, THERE WAS A LARGE AMOUNT OF CLEAR FLUID EMERGING FROM THE JOINT AND METAL WEAR DEBRIS SYNOVITIS WAS FOUND OVER THE GREATER TROCHANTER. THE SURGEON ATTEMPTED TO REMOVE THE HEAD; HOWEVER, THE TAPER ADAPTER WAS COLD-WELDED TO THE STEM. AFTER FURTHER ATTEMPTS, THE HEAD WAS ABLE TO BE REMOVED AND THERE WAS NO SIGNS OF TRUNNIONOSIS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591923 M2A-MAGNUM MOD HEAD PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 630530

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| R