BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 46MM

    MDR report key: 3870456 · Received June 12, 2014

    Report

    Report Number
    0001825034-2014-05492
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    April 19, 2013
    Report Date
    July 16, 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
    TX, 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. 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 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-05491 / 05492).

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THIS REPORT IS NUMBER 2 OF 5 MDR'S FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-05491 /-05492 /-07018 /-07019 /-07020).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2005. PATIENT'S LEGAL COUNSEL REPORTED PATIENT WAS REVISED ON (B)(6) 2013 DUE TO PATIENT ALLEGATIONS OF PAIN, LOSS OF RANGE OF MOTION, BONE/TISSUE DAMAGE, ELEVATED METAL ION LEVELS AND METALLOSIS. THE MODULAR HEAD, ACETABULAR CUP AND TAPER ADAPTER WERE REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. OPERATIVE REPORT RECEIVED NOTED PATIENT UNDERWENT A LEFT HIP REVISION ON (B)(6) 2013 DUE TO PAIN AND ELEVATED METAL ION LEVELS. OPERATIVE REPORT NOTED THE PRESENCE OF STRAW-COLORED JOINT FLUID, STAINED SOFT TISSUE, A FRACTURED GREATER TROCHANTER DURING REMOVAL OF THE TAPER ADAPTER, DISCOLORED TRUNNION, AND GRANULOMATOUS CYST WITH METALLIC STAINED DEBRIS. THE MODULAR HEAD, TAPER ADAPTER AND ACETABULAR CUP WERE REMOVED AND REPLACED. OPERATIVE REPORT NOTED PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2005 AND A RIGHT HIP REVISION PROCEDURE ON (B)(6) 2014. REVISION OPERATIVE REPORT RECEIVED NOTED THE REVISION WAS DUE TO PAIN AND ELEVATED METAL ION LEVELS. OPERATIVE REPORT NOTED THE PRESENCE OF MILKY COLORED FLUID, TISSUE STAINED WITH METALLIC DEBRIS, SYNOVITIS, AND CORROSION ON THE TRUNNION. THE MODULAR HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2005. PATIENT'S LEGAL COUNSEL REPORTED PATIENT WAS REVISED ON (B)(6) 2013 DUE TO PATIENT ALLEGATIONS OF PAIN, LOSS OF RANGE OF MOTION, BONE/TISSUE DAMAGE, ELEVATED METAL ION LEVELS AND METALLOSIS. THE MODULAR HEAD, ACETABULAR CUP AND TAPER ADAPTER WERE REMOVED AND REPLACED. 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
    347780 M2A-MAGNUM MOD HD SZ 46MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 780650

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R