BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM SYSTEM

    MDR report key: 6483388 · Received April 11, 2017

    Report

    Report Number
    0001825034-2017-02453
    Event Type
    Injury
    Date Received
    April 11, 2017
    Date of Event
    November 29, 2016
    Report Date
    September 25, 2019
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    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 WAS RETURNED. VISUAL INSPECTION OF THE RETURNED HEAD AND TAPER FOUND THE ITEMS TO HAVE HEAVY SCUFF / GOUGES. ALSO FOUND SCRATCHES ON THE POLISHED SURFACE OF THE HEAD. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE NEW INFORMATION DOES NOT CHANGE THE OUTCOME OF THE PREVIOUS INVESTIGATION. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS UNKNOWN IF PRODUCT IS BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS ITS LOCATION IS UNKNOWN. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MEDICAL PRODUCTS - M2A-MAGNUM TAPER INSERT P/N 139259 L/N UNKNOWN. UNKNOWN BALANCE MICROPLASTY STEM P/N UNKNOWN L/N UNKNOWN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-02452. 0001825034-2017-02453

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICES: M2A-MAGNUM PF CUP 56OD/50ID CATALOG#: US157856 LOT#: 296750, M2A MAGNUM 42-50M TPR INSRT +6 CATALOG#: 139259 LOT#: 410030, BALANCE MICROP STEM 12X80MM LT CATALOG#: 180211 LOT#: 131620. (B)(4). 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. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. 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 · 1

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

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT¿S LEFT HIP WAS REVISED APPROXIMATELY NINE YEARS POST-IMPLANTATION DUE TO PAIN, DISCOMFORT, INFLAMMATION, ELEVATED METAL ION LEVELS, AND METALLOSIS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262406 M2A MAGNUM SYSTEM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS 157450 226570

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R