BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 42MM

    MDR report key: 3201003 · Received July 2, 2013

    Report

    Report Number
    0001825034-2013-02431
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    May 13, 2013
    Report Date
    November 12, 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
    VA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. 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, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. 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." NUMBER 1 STATES, "MATERIAL SENSITIVITY REACTIONS." THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-02431 AND -05747).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT REPORTS THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006. PATIENT'S LEGAL COUNSEL FURTHER REPORTS THAT A REVISION PROCEDURE OCCURRED ON (B)(6) 2013 DUE TO PATIENT ALLEGATIONS OF DISCOMFORT AND ELEVATED COBALT AND CHROMIUM ION LEVELS. 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

    LEGAL COUNSEL FOR THE PATIENT REPORTS THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006. PATIENT'S LEGAL COUNSEL FURTHER REPORTS THAT A REVISION PROCEDURE OCCURRED ON (B)(6) 2013 DUE TO PATIENT ALLEGATIONS OF DISCOMFORT AND ELEVATED COBALT AND CHROMIUM ION LEVELS. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN PATIENT OPERATIVE NOTES REPORTS THE PATIENT UNDERWENT A BILATERAL REVISION (B)(6) 2013. REVISION SURGICAL NOTES REPORT FINDING SYNOVIAL FLUID WITH METAL DEBRIS AND GRAYISH DISCOLORATION OF THE CAPSULE ON THE RIGHT SIDE AND METAL DEBRIS WITH BROWNISH AND GRAYISH SYNOVIAL FLUID ON THE LEFT SIDE. THE FEMORAL HEADS WERE REMOVED FROM EACH HIP AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303423 M2A-MAGNUM MOD HD SZ 42MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 674280

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R