BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HEAD SZ 42MM

    MDR report key: 3811769 · Received May 15, 2014

    Report

    Report Number
    0001825034-2014-04023
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    March 21, 2014
    Report Date
    June 10, 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
    PA, 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 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 1825034-2014-04023 / 04024).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED AND ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. CORRECTION: CORRECTED TYPOGRAPHICAL ERROR REPORTING A LEFT TOTAL HIP ARTHROPLASTY OCCURRED ON (B)(6) 2009 TO READ (B)(6) 2009.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008, AND A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009. LEGAL COUNSEL FURTHER REPORTED PATIENT UNDERWENT BILATERAL HIP REVISION PROCEDURE ON (B)(6) 2014, DUE TO PATIENT ALLEGATIONS OF PAIN, ELEVATED METAL ION LEVELS, AND TISSUE AND BONE DESTRUCTION. THE MODULAR HEADS 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

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008, AND A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009. LEGAL COUNSEL FURTHER REPORTED PATIENT UNDERWENT BILATERAL HIP REVISION PROCEDURE ON (B)(6) 2014, DUE TO PATIENT ALLEGATIONS OF PAIN, ELEVATED METAL ION LEVELS, AND TISSUE AND BONE DESTRUCTION. THE MODULAR HEADS WERE REMOVED AND REPLACED. 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 (OP) NOTES REPORTS PATIENT WAS REVISED BILATERALLY DUE TO ELEVATED METAL ION LEVELS AND PAIN. OP REPORT FOR THE RIGHT HIP NOTES NO EVIDENCE OF METALLOSIS OR ALVAL AND NORMAL-LOOKING SYNOVIAL FLUID. OP REPORT FURTHER NOTES COMPONENTS WERE WELL FIXED AND IN APPROPRIATE POSITION. OP REPORT FOR THE LEFT HIP NOTES THE PRESENCE OF DARKER THAN NORMAL SYNOVIAL FLUID CONSISTENT WITH METALLOSIS AND WHITE PARTICULATE DEBRIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289343 M2A-MAGNUM MOD HEAD SZ 42MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 605500

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R