BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM 42-50MM TPR INSRT-3

    MDR report key: 3083313 · Received April 29, 2013

    Report

    Report Number
    0001825034-2013-01191
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    January 28, 2013
    Report Date
    April 11, 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
    UT, 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 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 1825034-2013-01190 / 01191).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, 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 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 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-01190 / 01191).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THE FOLLOW UP #1 MEDWATCH REPORT STATED THAT THE OPERATIVE NOTES CONFIRM THAT THE ACETABULAR CUP AND MODULAR HEAD WERE REMOVED AND REPLACED. THIS WAS MADE IN ERROR AS THE OPERATIVE NOTES CONFIRMED THAT THE ACETABULAR CUP WAS NOT REMOVED.

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006. SUBSEQUENTLY, LEGAL COUNSEL FOR PATIENT REPORTS PATIENT WAS REVISED ON (B)(6) 2013 DUE TO PATIENT ALLEGATIONS OF ELEVATED COCR LEVELS AND PAIN. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES THAT THE REVISION PROCEDURE THAT TOOK PLACE ON (B)(6) 2013 WAS DUE TO ELEVATED METAL ION LEVELS, A THICKENED BURSA AROUND THE GREATER TROCHANTER, SYNOVITIS, AND DISCOLORATION OF THE SYNOVIUM. THE OPERATIVE NOTES CONFIRM THAT THE ACETABULAR CUP 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.

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006. SUBSEQUENTLY, LEGAL COUNSEL FOR PATIENT REPORTS PATIENT WAS REVISED ON (B)(6) 2013 DUE TO PATIENT ALLEGATIONS OF ELEVATED COCR LEVELS AND PAIN. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE. 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

    PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006. SUBSEQUENTLY, LEGAL COUNSEL FOR PATIENT REPORTS PATIENT WAS REVISED ON (B)(6) 2013 DUE TO PATIENT ALLEGATIONS OF ELEVATED COCR LEVELS AND PAIN. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES THAT THE REVISION PROCEDURE THAT TOOK PLACE ON (B)(6) 2013 WAS DUE TO ELEVATED METAL ION LEVELS, A THICKENED BURSA AROUND THE GREATER TROCHANTER, SYNOVITIS, AND DISCOLORATION OF THE SYNOVIUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184822 M2A-MAGNUM 42-50MM TPR INSRT-3 PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 024740

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R