BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OFFSET TIB TRAY 5.0MM ADAPTOR

    MDR report key: 2992032 · Received March 7, 2013

    Report

    Report Number
    0001825034-2013-00511
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    June 13, 2012
    Report Date
    February 11, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBV
    PMA / PMN Number
    PK010212
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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. REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH (B)(4). THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: "EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 3 OF 5 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2012-00509 / 00513).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2009 AND FURTHER REPORTED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2011 DUE TO ALLEGED TIBIAL LOOSENING. PATIENT'S LEGAL COUNSEL ALLEGED THAT A SECOND REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2012 DUE TO DISASSOCIATION OF THE TIBIA STEM FROM THE TIBIA TRAY AND POSSIBLE INFECTION. A REVIEW OF INVOICE HISTORY CONFIRMED THE PRIMARY SURGERY DATE AND THAT THE TIBIAL COMPONENTS WERE REMOVED DURING THE REVISION PROCEDURE ON (B)(6) 2011. AN INVOICE COULD NOT BE LOCATED FOR THE REVISION PROCEDURE THAT WAS ALLEGED TO HAVE OCCURRED ON (B)(6) 2012. 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
    97833 OFFSET TIB TRAY 5.0MM ADAPTOR PROSTHESIS, KNEE MBV BIOMET ORTHOPEDICS N/A 919990

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R