BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM 42-50M TPR INSRT +6

    MDR report key: 2992071 · Received March 7, 2013

    Report

    Report Number
    0001825034-2013-00495
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    May 1, 2012
    Report Date
    August 12, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS NUMBER 3 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00493-1 / 00495-1).

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED DEVIATION OR ANOMALY. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 1 STATES, "MATERIAL SENSITIVITY REACTIONS." NUMBER 14 STATES: " 14. INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN. NUMBER 15 STATES, "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL ON METAL ARTICULATING SURFACES." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 3 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013 -00492 / 00495).

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT REPORTED THAT THE PATIENT UNDERWENT A RIGHT M2A HIP ARTHROPLASTY ON (B)(6) 2007. SUBSEQUENTLY, A REVISION WAS PERFORMED ON (B)(6) 2012 DUE TO ALLEGED PAIN, ELEVATED METAL ION LEVELS, AND AN ANTEVERTED CUP. MEDICAL RECORDS PROVIDED INDICATE DARK STAINING, DARK FLUID, TARNISHING AT THE TRUNNION OF HEAD AND METAL DEBRIS WAS PRESENT. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT REPORTED THAT THE PATIENT UNDERWENT A RIGHT M2A HIP ARTHROPLASTY ON (B)(6) 2007. SUBSEQUENTLY, A REVISION WAS PERFORMED ON (B)(6) 2012 DUE TO ALLEGED PAIN, ELEVATED METAL ION LEVELS, AND AN ANTEVERTED CUP. MEDICAL RECORDS PROVIDED INDICATE DARK STAINING, DARK FLUID, TARNISHING AT THE TRUNNION OF HEAD AND METAL DEBRIS WAS PRESENT. 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
    97031 M2A MAGNUM 42-50M TPR INSRT +6 PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 802080

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R