BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGC-S MODULAR TIBIAL BASE 70MM

    MDR report key: 1984239 · Received February 10, 2011

    Report

    Report Number
    1825034-2011-00096
    Event Type
    Injury
    Date Received
    February 10, 2011
    Date of Event
    February 3, 2010
    Report Date
    January 19, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    K833921
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    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: "EARLY OR LATE POSTOPERATIVE INFECTION, AND ALLERGIC REACTION." THE USER FACILITY WAS NOTIFIED OF THE EVENT ON (B)(6) 2011. THE USER FACILITY RESPONDED ON (B)(6) 2011 AND STATED THE SURGEON DID NOT FEEL THE INFECTION OCCURRED DUE TO ANY FAULT OF THE IMPLANT. THE SURGEON REPORTED THE PATIENT WAS SELF-MEDICATING WITH ANTIBIOTICS AND BECAME RESISTANT TO THEM; THEREFORE, THE INFECTION COULD NOT BE TREATED WITH REGULAR ANTIBIOTICS AND A REVISION PROCEDURE WAS NECESSARY. THE USER FACILITY WILL NOT BE FILING A MEDWATCH REPORT TO THE FDA. (B)(4).

    Description of Event or Problem · 1

    PATIENT REPORTED THAT TOTAL KNEE ARTHROPLASTY WAS PERFORMED ON (B)(6) 2006. SUBSEQUENTLY, SHE BEGAN TO EXPERIENCE PAIN AND HAD DIFFICULTY CLIMBING STAIRS AND SITTING. A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2010 TO REMOVE AND REPLACE ALL KNEE COMPONENTS DUE TO INFECTION. A REVIEW OF INVOICE HISTORY REVEALED CEMENT SPACER MOLDS WERE IMPLANTED IN HER KNEE AT THAT TIME. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AGC-S MODULAR TIBIAL BASE 70MM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 441130

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R