BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-RLOC LNR 10 DEG SZ 24/28MM

    MDR report key: 3936111 · Received July 15, 2014

    Report

    Report Number
    0001825034-2014-06186
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    February 4, 2014
    Report Date
    February 9, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK002379
    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: 1. MATERIAL SENSITIVITY REACTIONS. 14. INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN. 15. ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL ON METAL ARTICULATING SURFACES. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-00107 AND 06186).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP MEDWATCH IS BEING SUBMITTED TO REPORT THAT THIS MEDWATCH IS A DUPLICATE OF 1825034-2013-02660. THIS MEDWATCH 1825034-2014-06186 IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2005. SUBSEQUENTLY, PATIENT'S LEGAL COUNSEL FURTHER REPORTS PATIENT ALLEGATIONS OF PAIN, OSTEOARTHRITIS AND ELEVATED METAL ION LEVELS. ADDITIONAL INFORMATION PROVIDED IN PATIENT MEDICAL RECORDS INDICATE THE LEFT HIP WAS REVISED ON (B)(6) 2014 DUE TO PAIN, ADVERSE SOFT TISSUE REACTION, AND ELEVATED CHROMIUM AND COBALT LEVELS. THE PATIENT¿S OPERATIVE REPORT NOTED METALLOSIS, BLACKENED AMBER FLUID, AND OSTEOLYSIS. THE HEAD AND LINER WERE REMOVED. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS NOTED THAT ON (B)(6) 2013, (B)(6) 2013, AND (B)(6) 2013 PATIENT¿S BLOOD WAS TESTED. 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
    413745 M2A-RLOC LNR 10 DEG SZ 24/28MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 142160

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R