BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HEAD SZ 44MM

    MDR report key: 3852906 · Received June 6, 2014

    Report

    Report Number
    0001825034-2014-05310
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    October 28, 2010
    Report Date
    July 15, 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
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS: " UNDESIRABLE SHORTENING OF LIMB. " 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 3 MDR'S FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-05310 /-05311 /-06791 ).

    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.¿ NUMBER 15 STATES, ¿ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL-ON-METAL ARTICULATING SURFACES.¿ THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-05310 / 05311).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010 AND A REVISION PROCEDURE ON (B)(6) 2010 DUE TO PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, LACK OF MOBILITY, LOSS OF RANGE OF MOTION, METAL POISONING, METALLOSIS AND ELEVATED METAL ION LEVELS. 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 RIGHT HIP REVISION IN (B)(6) 2010 DUE TO A LEG LENGTH DISCREPANCY. OPERATIVE REPORT NOTED THE PRESENCE OF AN EFFUSION, A PREVIOUS POSTERIOR REPAIR HAD FAILED AND THE FEMUR FRACTURED DURING REMOVAL OF THE STEM. ALL COMPONENTS WERE REMOVED AND REPLACED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010 AND A REVISION PROCEDURE ON (B)(6) 2010, DUE TO PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, LACK OF MOBILITY, LOSS OF RANGE OF MOTION, METAL POISONING, METALLOSIS AND ELEVATED METAL ION LEVELS. 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
    331152 M2A-MAGNUM MOD HEAD SZ 44MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 353870

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R