BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 54ODX48ID

    MDR report key: 8037906 · Received November 5, 2018

    Report

    Report Number
    0001825034-2018-10215
    Event Type
    Injury
    Date Received
    November 5, 2018
    Date of Event
    May 21, 2015
    Report Date
    April 23, 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
    PA, 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. BLOOD LEVELS SHOWED ELEVATED CHROMIUM AND COBALT LEVELS. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES WOULD CONTRIBUTE TO REPORTED EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. 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). CONCOMITANT MEDICAL PRODUCTS: 157448 ¿ M2A MAGNUM HEAD ¿ 233810. 11-103204 ¿ TAPERLOC FEMORAL STEM ¿ 483380. 139254 ¿ M2A MAGNUM TAPER - 210100. THERAPY DATE: UNKNOWN. CUSTOMER HAS INDICATED THAT PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE PRODUCT REMAINS IMPLANTED AT THIS TIME. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT; PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-10214.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT HAS UNDERGONE MULTIPLE BLOOD WORKUPS STARTING APPROXIMATELY 7 YEARS POST PRIMARY LEFT TOTAL HIP ARTHROPLASTY. PATIENT WAS NOTED TO HAVE ELEVATED METAL ION LEVELS. NO REVISION SURGERY HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    879289 M2A-MAGNUM PF CUP 54ODX48ID PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 980740

    Patients

    Seq Age Sex Outcome Treatment
    1 Other