BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HEAD SZ 46MM

    MDR report key: 3841347 · Received May 30, 2014

    Report

    Report Number
    0001825034-2014-05077
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 15, 2012
    Report Date
    October 9, 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
    KY, 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 14 STATES, ¿INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN.¿

    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.

    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. 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.¿ THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 1 OF 3 MDR'S FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-05077 AND 08305 / 08306).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009 AND REVISION PROCEDURES ON AN UNKNOWN DATE IN (B)(6) 2012 AND ON (B)(6) 2013 DUE TO PATIENT ALLEGATIONS OF PAIN. 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) 2009 AND REVISION PROCEDURES ON AN UNKNOWN DATE IN (B)(6) 2012 AND ON (B)(6) 2013 DUE TO PATIENT ALLEGATIONS OF PAIN. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. OPERATIVE REPORT RECEIVED NOTED PATIENT UNDERWENT A RIGHT HIP REVISION IN (B)(6) 2012 IN (B)(6) DUE TO AN UNKNOWN REASON. AT THAT TIME ALL BIOMET COMPONENTS WERE REMOVED AND REPLACED WITH A COMPETITOR'S (B)(6) COMPONENTS. THE (B)(6) 2013 REVISION IS NOT RELATED TO BIOMET COMPONENTS.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009 AND REVISION PROCEDURES ON AN UNKNOWN DATE IN (B)(6) 2012 AND ON (B)(6) 2013 DUE TO PATIENT ALLEGATIONS OF PAIN. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. OPERATIVE REPORT RECEIVED NOTED PATIENT UNDERWENT A RIGHT HIP REVISION IN (B)(6) 2012 IN (B)(6) DUE TO AN UNKNOWN REASON. AT THAT TIME ALL BIOMET COMPONENTS WERE REMOVED AND REPLACED WITH A COMPETITOR'S (B)(6) COMPONENTS. THE (B)(6) 2013 REVISION IS NOT RELATED TO BIOMET COMPONENTS. ADDITIONAL INFORMATION RECEIVED IN PATIENT'S OPERATIVE REPORT REVEALED RIGHT HIP REVISION WAS PERFORMED ON (B)(6) 2012 DUE TO PAIN, METALLOSIS, PSEUDOTUMOR, CYSTS, AND LOOSENING OF THE CUP AND STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319479 M2A-MAGNUM MOD HEAD SZ 46MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 609230

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Congenital Anomaly| H