BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 52ODX46ID

    MDR report key: 3972925 · Received August 1, 2014

    Report

    Report Number
    0001825034-2014-06699
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    August 25, 2011
    Report Date
    July 21, 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
    MO, 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, 1. MATERIAL SENSITIVITY REACTIONS. 6. INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS. 14. INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN. 15. 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 1825034-2014-06699 / 06700).

    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.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6), 2009 AND A REVISION PROCEDURE ON (B)(6), 2011 DUE TO PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE/TISSUE, LACK OF MOBILITY, LOSS OF RANGE OF MOTION, DYSFUNCTION, SORENESS, AND ELEVATED METAL ION LEVELS. PATIENT¿S LEGAL COUNSEL FURTHER REPORTED GRAYISH FLUID AND GRAYISH LINING MATERIAL CONSISTENT WITH METAL WEAR WERE ALLEGEDLY NOTED DURING THE REVISION PROCEDURE. 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 LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009 AND A REVISION PROCEDURE ON (B)(6) 2011 DUE TO PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE/TISSUE, LACK OF MOBILITY, LOSS OF RANGE OF MOTION, DYSFUNCTION, SORENESS, AND ELEVATED METAL ION LEVELS. PATIENT'S LEGAL COUNSEL FURTHER REPORTED GRAYISH FLUID AND GRAYISH LINING MATERIAL CONSISTENT WITH METAL WEAR WERE ALLEGEDLY NOTED DURING THE REVISION PROCEDURE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN REVISION OPERATIVE NOTES CONFIRMED THE PRESENCE OF GRAY FLUID AND LINING MATERIAL CONSISTENT WITH METAL WEAR. THE ACETABULAR CUP, MODULAR HEAD AND TAPER INSERT WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450549 M2A-MAGNUM PF CUP 52ODX46ID PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 789750

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R