BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 58ODX52ID

    MDR report key: 7658891 · Received July 3, 2018

    Report

    Report Number
    0001825034-2018-04373
    Event Type
    Injury
    Date Received
    July 3, 2018
    Date of Event
    October 18, 2016
    Report Date
    November 28, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT 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). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, DUE TO REMAINING IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: 157452, M2A-MAGNUM MOD HD SZ 52MM, 972960, 139268, M2A-MAGNUM 52-60MM TPR INS STD, 183250, 103205, TAPERLOC POR FMRL 11X142, 677160. CONSUMER - ATTORNEY. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 04374.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT RECEIVED BILATERAL METAL ON METAL HIP IMPLANTS. ELEVATED METAL IONS WERE REPORTED APPROXIMATELY 7.5 YEARS POST IMPLANTATION OF RIGHT HIP, AND APPROXIMATELY 6.5 YEARS POST IMPLANTATION OF LEFT HIP. PATIENT UNDERWENT REVISION ON RIGHT HIP, BUT HAS NOT YET RECEIVED MEDICAL INTERVENTION FOR LEFT HIP. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501221 M2A-MAGNUM PF CUP 58ODX52ID HIP PROSTHESIS KWA ZIMMER BIOMET, INC. N/A 756790

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other