BEUDAMED
    FDA Adverse Event Injury Summary report: N

    32MM M2A MOD HEAD +9MM NK SKTD

    MDR report key: 3200892 · Received July 2, 2013

    Report

    Report Number
    0001825034-2013-02419
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    June 3, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWY
    PMA / PMN Number
    PK003363
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 14 STATES, "POSTOPERATIVE BONE FRACTURE AND PAIN." AND NUMBER 15 STATES, "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL ON METAL ARTICULATING SURFACES." THIS REPORT IS NUMBER 2 OF 3 MDRS FILED FOR THIS EVENT (REFERENCE 1825034-2013-02418 /02420). 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.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT REPORTED THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2005. LEGAL COUNSEL FOR PATIENT REPORTS PATIENT ALLEGATIONS OF PAIN, DISCOMFORT, TISSUE/BONE DESTRUCTION, INFLAMMATION, ELEVATED METAL ION LEVELS AND METALLOSIS. OPERATIVE NOTES INDICATE THE PATIENT WAS REVISED (B)(6) 2012 DUE TO METALLOSIS AND THE PRESENCE OF A PSEUDOTUMOR. THE ACETABULAR COMPONENT, MODULAR HEAD AND TAPER INSERT WERE REMOVED AND REPLACED. 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 REPORTED THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2005. LEGAL COUNSEL FOR PATIENT REPORTS PATIENT ALLEGATIONS OF PAIN, DISCOMFORT, TISSUE/BONE DESTRUCTION, INFLAMMATION, ELEVATED METAL ION LEVELS AND METALLOSIS. LEGAL COUNSEL REPORTS AN ALLEGED REVISION WAS PERFORMED ON UNKNOWN DATE TO REMOVE HIP IMPLANT. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303375 32MM M2A MOD HEAD +9MM NK SKTD PROSTHSIS, HIP KWY BIOMET ORTHOPEDICS N/A 790500

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R