BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGC COMPONENT

    MDR report key: 2838510 · Received November 19, 2012

    Report

    Report Number
    0001825034-2012-02448
    Event Type
    Injury
    Date Received
    November 19, 2012
    Date of Event
    April 23, 2012
    Report Date
    October 23, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VE
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE FOLLOWING COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. DATE OF EVENT - UNKNOWN. BRAND NAME - UNKNOWN. PRODUCT CODE - UNKNOWN. PRODUCT IDENTIFICATION & EXPIRATION DATE - UNKNOWN. DATE IMPLANTED - UNKNOWN. DATE EXPLANTED - UNKNOWN. MANUFACTURE DATE - UNKNOWN. THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY WHEN THE REVISION OCCURRED AND THIS PRODUCT WAS NOT MANUFACTURED BY BIOMET, INC. BUT BIOMET (B)(4), WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. FURTHER, THE AGC COMPONENTS THAT WERE IDENTIFIED IN THE REVISION INVOICE (FORWARDED TO BIOMET INC.) ARE NOT CLEARED FOR DISTRIBUTION IN THE UNITED STATES. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. EXPIRATION DATE - UNKNOWN. DATE IMPLANTED - 2007. MANUFACTURE DATE - UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT BILATERAL TOTAL KNEE ARTHROPLASTY IN 1997. SUBSEQUENTLY, A BILATERAL REVISION WAS PERFORMED IN 2007 DUE TO ALLEGED MEDICAL INDICATIONS. APPROXIMATELY, TWO YEARS LATER PATIENT ALLEGED DISCOMFORT IN RIGHT LEG. ON (B)(4) 2012, PATIENT WAS REVISED ALLEGEDLY DUE TO THE HEAD OF A SCREW ON THE PROSTHESIS WAS SEVERED AND LOOSE CAUSING PAIN AND LIMITED JOINT FUNCTION. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT BILATERAL TOTAL KNEE ARTHROPLASTY IN 1997. SUBSEQUENTLY, A BILATERAL REVISION WAS PERFORMED IN (B)(6) 2006 DUE TO ALLEGED MEDICAL INDICATIONS. A TOTAL RIGHT HIP ARTHROPLASTY WAS PERFORMED (B)(6) 2008. APPROXIMATELY, TWO YEARS LATER PATIENT ALLEGES DISCOMFORT ON RIGHT LEG. ON (B)(6) 2012, SURGEON ALLEGEDLY INDICATED THE NEED FOR REVISION DUE TO THE HEAD OF A SCREW ON THE PROSTHESIS WAS SEVERED AND LOOSE CAUSING PAIN AND LIMITED JOINT FUNCTION. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AGC COMPONENT PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R