BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM 42-50MM TPR INSRT-6

    MDR report key: 3113609 · Received May 15, 2013

    Report

    Report Number
    0001825034-2013-01505
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    August 20, 2012
    Report Date
    April 15, 2013
    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 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 15 STATES, "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL ON METAL ARTICULATING SURFACES." THIS REPORT IS NUMBER 3 OF 4 MDRS FILED FOR THIS EVENT (REFERENCE 1825034-2013-01503 / 01506). THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION RECEIVED IN MEDICAL RECORDS, WHICH 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, 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, OR EXCESSIVE ACTIVITY." NUMBER 8 STATES, "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING. MUSCLE AND FIBROUS TISSUE LAXITY MAY ALSO CONTRIBUTE TO THESE CONDITIONS."

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT REPORTED THAT THE PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. SUBSEQUENTLY, LEGAL COUNSEL FOR PATIENT ALLEGES A REVISION WAS PERFORMED ON (B)(6) 2012 DUE TO PATIENT ALLEGATIONS OF PAIN, SWELLING, TISSUE/BONE DESTRUCTION, LACK OF MOBILITY, LOCAL TISSUE REACTION AND METALLOSIS. IT IS UNKNOWN WHETHER A REVISION PROCEDURE HAS OCCURRED. 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 TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. SUBSEQUENTLY, LEGAL COUNSEL FOR PATIENT ALLEGES A REVISION WAS PERFORMED (B)(6) 2012 DUE TO PATIENT ALLEGATIONS OF PAIN, SWELLING, TISSUE/BONE DESTRUCTION, LACK OF MOBILITY, LOCAL TISSUE REACTION AND METALLOSIS. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES THAT THE REVISION PROCEDURE THAT TOOK PLACE ON (B)(6) 2012 WAS DUE TO ACETABULAR CUP LOOSENING, DISLOCATION AND FLUID. THE OPERATIVE NOTES CONFIRM THAT THE ACETABULAR CUP, TAPER ADAPTER AND MODULAR HEAD 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
    215573 M2A-MAGNUM 42-50MM TPR INSRT-6 PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 976360

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R