BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 48MM

    MDR report key: 3771327 · Received April 24, 2014

    Report

    Report Number
    0001825034-2014-03221
    Event Type
    Injury
    Date Received
    April 24, 2014
    Date of Event
    October 23, 2013
    Report Date
    December 1, 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
    GA, 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

    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 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 6 STATES, "INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS." 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 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 A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2013 DUE TO PATIENT ALLEGATIONS OF PAIN, LOSS OF RANGE OF MOTION, BONE/TISSUE DAMAGE, DIFFICULTY WALKING, ELEVATED METAL ION LEVELS AND METALLOSIS. THE MODULAR HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED. ADDITIONAL INFORMATION PROVIDED IN PATIENT MEDICAL RECORDS INDICATE POSTOPERATIVELY OF TOTAL HIP ARTHROPLASTY, PATIENT HAD A PERIPROSTHETIC FRACTURE AND SUBSIDENCE; THEREFORE UNDERWENT ORIF OF THE PROXIMAL FEMUR ON AN UNKNOWN DATE. FURTHER INFORMATION PROVIDED IN PATIENT MEDICAL RECORDS INDICATE LEFT HIP REVISION PERFORMED ON (B)(6) 2013 WAS DUE TO PAIN. THE PATIENT'S OPERATIVE REPORT NOTED GRAYISH-COLORED FLUID, GRAYISH SOFT TISSUES WITH APPEARANCE OF METALLOSIS. 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 A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2013 DUE TO PATIENT ALLEGATIONS OF PAIN, LOSS OF RANGE OF MOTION, BONE/TISSUE DAMAGE, DIFFICULTY WALKING, ELEVATED METAL ION LEVELS AND METALLOSIS. THE MODULAR HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED. 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
    249263 M2A-MAGNUM MOD HD SZ 48MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 946080

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R