BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM MODULAR HEAD +3MM NK

    MDR report key: 3190405 · Received June 26, 2013

    Report

    Report Number
    0001825034-2013-02257
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    October 23, 2012
    Report Date
    September 17, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK082446
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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.

    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.¿ 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 THE PATIENT REPORTS THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010. LEGAL COUNSEL FOR PATIENT REPORTS PATIENT ALLEGATIONS OF PAIN AND ELEVATED METAL ION LEVELS. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2012. THIS COMPLAINT 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) 2010. LEGAL COUNSEL FOR PATIENT REPORTS PATIENT ALLEGATIONS OF PAIN AND ELEVATED METAL ION LEVELS. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2012. MEDICAL RECORDS RECEIVED (B)(4) 2013. ADDITIONAL INFORMATION RECEIVED IN PATIENT'S REVISION OPERATIVE REPORT INDICATES THAT THE REVISION WAS DUE TO PAIN. OPERATIVE REPORT NOTES THAT THE PSOAS TENDON WAS OVERLY TIGHT AND CAUSING PAIN. METAL ION LEVELS WERE WITHIN RANGE WITH NO SIGNIFICANT INFLAMMATION OR FLUID ACCUMULATION. OPERATIVE REPORT INDICATES A THICKENED PSEUDOCAPSULE AND DENSE-CAPSULAR SCAR TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291180 M2A 38MM MODULAR HEAD +3MM NK PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 818370

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R