BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET OFFSET TIBIAL TRAY 67MM

    MDR report key: 4267245 · Received November 20, 2014

    Report

    Report Number
    0001825034-2014-08675
    Event Type
    Injury
    Date Received
    November 20, 2014
    Date of Event
    April 24, 2014
    Report Date
    October 29, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBV
    PMA / PMN Number
    PK010212
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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 RELATED TO THE EVENT. REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH ISO 11137-2. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS: "EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION." THIS REPORT IS NUMBER 5 OF 14 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-08260 & 08672 - 08684).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2013. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2014 DUE TO PAIN. IT WAS FURTHER REPORTED PATIENT IS STILL EXPERIENCING PAIN. ADDITIONAL INFORMATION RECEIVED NOTED THAT THE PATIENT UNDERWENT A RIGHT KNEE REVISION ON (B)(6) 2013 WHERE COMPONENTS WERE REMOVED AND REPLACED WITH CEMENT SPACER MOLDS. ON (B)(6) 2013 PATIENT UNDERWENT A SECOND REVISION PROCEDURE WHERE SPACER MOLDS WERE REMOVED AND REPLACED WITH CEMENT SPACER MOLDS. ON (B)(6) 2013 PATIENT UNDERWENT A THIRD REVISION PROCEDURE WHERE SPACER MOLDS WERE REMOVED AND REPLACED WITH CEMENT SPACER MOLDS. ON (B)(6) 2014 PATIENT UNDERWENT A FOURTH REVISION PROCEDURE WHERE THE SPACERS MOLD WERE REMOVED AND A TOTAL KNEE WAS REIMPLANTED. ON (B)(6) 2014 ALL COMPONENTS WERE REMOVED AND REPLACED WITH CEMENT SPACER MOLDS. IN (B)(6) 2014 PATIENT'S LEG WAS AMPUTATED DUE TO SEVERE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753255 BIOMET OFFSET TIBIAL TRAY 67MM PROSTHESIS, KNEE MBV BIOMET ORTHOPEDICS N/A 148690

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R