BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 48MM

    MDR report key: 3872374 · Received June 13, 2014

    Report

    Report Number
    0001825034-2014-05498
    Event Type
    Injury
    Date Received
    June 13, 2014
    Report Date
    June 4, 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
    AL, 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. UPON REVIEW OF THE REVISION OP REPORT, IT APPEARS THAT THE PROCEDURE REPORTED OCCURRING ON (B)(6) 2013 IS THE SECOND STAGE OF A TWO-STAGE REVISION AND NOT A SEPARATE REVISION PROCEDURE. 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 4 STATES, ¿LOOSENING OR MIGRATION OF THE IMPLANTS MAY OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, EXCESSIVE ACTIVITY.¿ NUMBER 10 STATES, ¿FRETTING AND CREVICE CORROSION MAY OCCUR AT INTERFACES BETWEEN 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 PATIENT¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 3 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-02522 / -02523 AND -05498 / -05499).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007. PATIENT'S LEGAL COUNSEL REPORTS PATIENT ALLEGATIONS OF PAIN, BONE/TISSUE DAMAGE AND METALLOSIS. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2013. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN PATIENT¿S OPERATIVE (OP) NOTES DATED (B)(6) 2013 REPORTS, PATIENT WAS REVISED DUE TO ACUTE LATE SEPTIC ARTHRITIS IN PREVIOUSLY IMPLANTED RIGHT TOTAL HIP REPLACEMENT. REVISION OP REPORT NOTES THE PRESENCE OF NECROTIC-APPEARING FAT, RUBBERY GRANULATION TISSUE, AND CORROSION AT THE JUNCTION. IN ADDITION, OP NOTES REPORT NO SIGN OF METALLOSIS, PSEUDOTUMOR FORMATION, OR OSTEOLYSIS. THE CUP, HEAD, AND TAPER INSERT WERE REMOVED AND REPLACED. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS REPORTS THE PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007. THERE HAS BEEN NO REPORTED REVISION PROCEDURE FOR THE LEFT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349406 M2A-MAGNUM MOD HD SZ 48MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 095050

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization