BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM 42-50MM TPR INSRT-6

    MDR report key: 5195500 · Received November 2, 2015

    Report

    Report Number
    0001825034-2015-04482
    Event Type
    Injury
    Date Received
    November 2, 2015
    Date of Event
    November 6, 2014
    Report Date
    October 6, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. 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 6 STATES, "INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS." NUMBER 14 STATES, "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 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2015-03207-1 / 03208-1 / 04482).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT AN INITIAL LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007. SUBSEQUENTLY, PATIENT'S LEGAL COUNSEL FURTHER REPORTS PATIENT WAS REVISED ON (B)(6) 2014 DUE TO ELEVATED METAL ION LEVELS, METALLOSIS, PAIN AND LIMITED MOBILITY. THE MODULAR HEAD, TAPER ADAPTER AND ACETABULAR CUP WERE REMOVED AND REPLACED AND A LINER WAS IMPLANTED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN OPERATIVE REPORT NOTED PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2014 DUE TO ELEVATED METAL ION LEVELS, METALLOSIS, PAIN, LIMITED MOBILITY AND INCREASED ABDUCTION ASSOCIATED WITH DECREASED ANTEVERSION OF THE ACETABULAR COMPONENT. OPERATIVE REPORT FURTHER NOTED GRAY FLUID AND CORROSION OF THE TAPER DURING THE REVISION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726699 M2A-MAGNUM 42-50MM TPR INSRT-6 PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 793600

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R