BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 50ODX44ID

    MDR report key: 5386481 · Received January 22, 2016

    Report

    Report Number
    0001825034-2016-00257
    Event Type
    Injury
    Date Received
    January 22, 2016
    Date of Event
    August 22, 2013
    Report Date
    January 11, 2016
    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 4 STATES, "LOOSENING OR MIGRATION OF THE IMPLANTS MAY OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, EXCESSIVE ACTIVITY." 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 5 OF 5 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2015-05142-1 / 2015-05143-1 / 2015-05144-1 / 2016-00256 / 2016-00257).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S LEGAL COUNSEL THAT PATIENT UNDERWENT AN INITIAL RIGHT HIP ARTHROPLASTY ON (B)(6) 2006. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2013 DUE TO ALLEGATIONS OF PAIN AND ELEVATED COBALT ION LEVELS. PATIENT WAS REVISED AGAIN ON (B)(6) 2013 DUE TO INFECTION. DURING THE PROCEDURE, ALL COMPONENTS WERE REMOVED AND SPACERS WERE IMPLANTED. ON (B)(6) 2014, THE SPACERS WERE REMOVED AND PATIENT UNDERWENT RE-IMPLANTATION. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT DURING THE REVISION PROCEDURE ON (B)(6) 2013, LOOSENING OF THE CUP, DISCOLORED JOINT FLUID, HYPERTROPHIC SYNOVIAL TISSUE, AND DEFICIENCY IN THE ANTERIOR WALL WERE NOTED. PATIENT UNDERWENT AN IRRIGATION AND DEBRIDEMENT PROCEDURE BETWEEN (B)(6) 2013 AND (B)(6) 2013. ADDITIONAL INFORMATION FURTHER REPORTED THAT DURING THE REVISION PROCEDURE ON (B)(6) 2013, PURULENT FLUID AND DENUDED FATTY TISSUE SUGGESTIVE OF LONG TERM AND INFECTED HEMATOMA WERE NOTED. A TROCHANTERIC OSTEOTOMY WAS PERFORMED TO REMOVE THE WELL FIXED STEM AND A PIECE OF MEDIAL CALCAR FRACTURED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43315 M2A-MAGNUM PF CUP 50ODX44ID PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 355370

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R