BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 52ODX46ID

    MDR report key: 3203835 · Received July 3, 2013

    Report

    Report Number
    0001825034-2013-02475
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    October 9, 2012
    Report Date
    April 22, 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
    NY, 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." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 1 OF 8 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-02475 / 02482).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED THAT A BILATERAL PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010 AND A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010. SUBSEQUENTLY, LEGAL COUNSEL FOR PATIENT REPORTS PATIENT WAS REVISED ON THE RIGHT HIP ON (B)(6) 2012 AND THE LEFT HIP ON (B)(6) 2012 DUE TO PATIENT ALLEGATIONS OF PAIN, LOSS OF RANGE OF MOTION, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, METAL POISONING AND METALLOSIS. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE. 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

    PATIENT'S LEGAL COUNSEL REPORTED THAT A BILATERAL PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6), 2010 AND A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6), 2010. SUBSEQUENTLY, LEGAL COUNSEL FOR PATIENT REPORTS PATIENT WAS REVISED ON THE RIGHT HIP ON (B)(6), 2012 AND THE LEFT HIP ON (B)(6), 2012 DUE TO PATIENT ALLEGATIONS OF PAIN, LOSS OF RANGE OF MOTION, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, METAL POISONING AND METALLOSIS. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN PATIENT OPERATIVE (OP) NOTES REPORTS THE PATIENT'S LEFT HIP WAS REVISED (B)(6), 2012 DUE TO METALLOSIS. THE HEAD WAS REMOVED AND REPLACED. OP NOTES FOR THE RIGHT HIP REVISION DATED (B)(6), 2012 REPORT THE PRESENCE OF CLEAR YELLOW FLUID WITH NO METAL OBSERVED IN SAID FLUID. THE HEAD WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306071 M2A-MAGNUM PF CUP 52ODX46ID PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 835960

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Hospitalization| R