BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM 12/14 TPR 42-50 -3

    MDR report key: 3094457 · Received May 6, 2013

    Report

    Report Number
    0001825034-2013-01259
    Event Type
    Injury
    Date Received
    May 6, 2013
    Date of Event
    April 22, 2011
    Report Date
    April 8, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK061423
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    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 14 STATES, ¿INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN.¿ 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 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-01257-1/001259-1).

    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. THIS REPORT IS NUMBER 3 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-01257 / 001259). THE REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT REPORTED THAT THE PATIENT UNDERWENT M2A HIP ARTHROPLASTY ON (B)(6) 2008 SUBSEQUENTLY, PATIENT ALLEGES A REVISION PROCEDURE WAS PERFORMED (B)(6) 2013 DUE TO ALLEGED PAIN, DISCOMFORT, SORENESS, DYSFUNCTION, LOSS OF RANGE OF MOTION, ELEVATED METAL ION LEVELS AND METALLOSIS. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT REPORTED THAT THE PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. PATIENT'S LEGAL COUNSEL REPORTS PATIENT ALLEGATIONS OF PAIN, INFLAMMATION, BONE/TISSUE DAMAGE, LACK OF MOBILITY AND METALLOSIS. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2011. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES THAT THE REVISION PROCEDURE THAT TOOK PLACE ON (B)(6) 2011 WAS DUE TO PAIN, INSTABILITY, AND LIMITATION OF FUNCTION. OPERATIVE NOTES STATE THE ACETABULAR COMPONENT WAS LOOSE AND THAT SYNOVIAL FLUID AND STAINED TISSUE WERE PRESENT. THE OPERATIVE NOTES CONFIRM THAT THE ACETABULAR COMPONENT, MODULAR HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED WITH COMPETITOR PRODUCT. THE 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
    196361 M2A-MAGNUM 12/14 TPR 42-50 -3 PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 377080

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R