BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 44MM

    MDR report key: 3833563 · Received May 27, 2014

    Report

    Report Number
    0001825034-2014-04823
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    August 7, 2013
    Report Date
    August 15, 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
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION THAT 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: "MATERIAL SENSITIVITY REACTIONS." THIS REPORT IS NUMBER 2 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-03649 AND 2014- 04823 /-07564 /-07565).

    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 THESE TYPES OF EVENTS CAN OCCUR UNDER POSSIBLE ADVERSE EFFECTS: 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 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 1825034-2013-03649 AND 2014- 04823).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2010. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2013 ALLEGEDLY DUE TO A LOOSE ACETABULAR CUP. THE ACETABULAR CUP AND MODULAR HEAD WERE REMOVED AND REPLACED. ADDITIONAL INFORMATION RECEIVED FROM PATIENT'S LEGAL COUNSEL REPORT PATIENT ALLEGATIONS OF PAIN, INFLAMMATION, ELEVATED COBALT AND CHROMIUM, DIFFICULTY AMBULATING, PROBLEMS SITTING, STANDING AND MOVING UP AND DOWN STAIRS, IMPAIRMENT AND DISFIGUREMENT. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. OPERATIVE REPORT NOTED PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010 AND A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. OPERATIVE REPORT NOTED PATIENT UNDERWENT A LEFT HIP REVISION ON (B)(6) 2013 AND NOTED THE PRESENCE OF METALLOSIS. THE MODULAR HEAD, TAPER ADAPTER AND ACETABULAR CUP WERE REMOVED AND REPLACED. NO REVISION PROCEDURE HAS BEEN REPORTED FOR THE RIGHT HIP.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2010. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2013 ALLEGEDLY DUE TO A LOOSE ACETABULAR CUP. THE ACETABULAR CUP AND MODULAR HEAD WERE REMOVED AND REPLACED. ADDITIONAL INFORMATION RECEIVED FROM PATIENT¿S LEGAL COUNSEL REPORT PATIENT ALLEGATIONS OF PAIN, INFLAMMATION, ELEVATED COBALT AND CHROMIUM, DIFFICULTY AMBULATING, PROBLEMS SITTING, STANDING AND MOVING UP AND DOWN STAIRS, IMPAIRMENT AND DISFIGUREMENT. 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
    310427 M2A-MAGNUM MOD HD SZ 44MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 207750

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R