BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM MODULAR HEAD -6MM NK

    MDR report key: 3183661 · Received June 22, 2013

    Report

    Report Number
    0001825034-2013-02113
    Event Type
    Injury
    Date Received
    June 22, 2013
    Date of Event
    May 24, 2010
    Report Date
    May 28, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 1 STATES, ¿MATERIAL SENSITIVITY REACTIONS.¿ NUMBER 8 STATES, "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING." 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.

    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. CORRECTED DATA: EVENT DESCRIPTION - THIS REPORT IS FOR A RIGHT HIP AND NOT A LEFT HIP AS ORIGINALLY REPORTED. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-02113-1 AND 03768).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT REPORTS THAT PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6), 2008. PATIENT'S LEGAL COUNSEL FURTHER REPORTS THAT A RIGHT REVISION PROCEDURE OCCURRED ON (B)(6) 2010 DUE TO PATIENT ALLEGATIONS OF ELEVATED COCR ION LEVELS, PAIN, LOSS OF RANGE OF MOTION, GRINDING, PROBABLE SUBLUXATION OF HIP. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE. 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 THE PATIENT REPORTS THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. PATIENT'S LEGAL COUNSEL FURTHER REPORTS THAT A REVISION PROCEDURE OCCURRED ON (B)(6) 2010 DUE TO PATIENT ALLEGATIONS OF ELEVATED COCR ION LEVELS, PAIN, LOSS OF RANGE OF MOTION, GRINDING, PROBABLE SUBLUXATION OF HIP. OPERATIVE REPORTS STATE THAT THE PATIENT¿S SYNOVIUM WAS STAINED BLACK WITH METAL DEBRIS. ALSO, CULTURES CONFIRMED THE PATIENT¿S HIP JOINT WAS INFECTED. THE MODULAR HEAD AND ACETABULAR COMPONENT 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
    284079 M2A 38MM MODULAR HEAD -6MM NK PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 763950

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R