BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HEAD SZ 50MM

    MDR report key: 3810243 · Received May 14, 2014

    Report

    Report Number
    0001825034-2014-03978
    Event Type
    Injury
    Date Received
    May 14, 2014
    Date of Event
    August 26, 2009
    Report Date
    November 4, 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
    MN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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.

    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 ASSOCIATED 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 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-03977 / 03978).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2005, AND A REVISION PROCEDURE ON (B)(6) 2009, DUE TO PATIENT ALLEGATIONS OF PAIN, ELEVATED METAL ION LEVELS, AND TISSUE AND BONE DAMAGE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS CONFIRMED THE SURGERY DATES. THE PATIENT'S OPERATIVE REPORT FOR THE (B)(6) 2009 REVISION NOTED A LOOSE ACETABULAR COMPONENT. DURING THE REVISION PROCEDURE, THE BIOMET HEAD AND CUP WERE REMOVED AND REPLACED WITH A BIOMET HEAD AND COMPETITOR'S CUP.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2005, AND A REVISION PROCEDURE ON (B)(6) 2009, DUE TO PATIENT ALLEGATIONS OF PAIN, ELEVATED METAL ION LEVELS, AND TISSUE AND BONE DAMAGE. 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
    288448 M2A-MAGNUM MOD HEAD SZ 50MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 606350

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R