BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REGENEREX BIOMET PRIMARY TIBIAL TRAY 75MM WITH LOCKING BAR

    MDR report key: 6308990 · Received February 7, 2017

    Report

    Report Number
    0001825034-2017-00519
    Event Type
    Injury
    Date Received
    February 7, 2017
    Date of Event
    January 5, 2017
    Report Date
    February 7, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBH
    PMA / PMN Number
    PK080361
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF ADDITIONAL INFORMATION THIS EVENT WILL BE REPORTED ON 1825034-2017-03697.

    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. BIOMET KNEE SYSTEM MODULAR FINNED STEM WITH SCREW CATALOG 141314 LOT 304970; VANGAURD KNEE SYSTEM CR FEMORAL ¿ LEFT 67.5MM CATALOG 183070 LOT 800010; VANGUARD KNEE SYSTEM AS TIBIAL BEARING 10MM 75MM CATALOG 189080 LOT 553000; BIOMET MODULAR TIBIAL LOCKING BAR CATALOG 141205 LOT 125220. THIS REPORT IS NUMBER 3 OF 6 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2017-00517 / 1825034-2017-00522).

    Description of Event or Problem · 1

    PATIENT UNDERWENT A TOTAL KNEE REVISION DUE TO CONTINUED PAIN AND STIFFNESS 17 DAYS POST BEARING EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89684 REGENEREX BIOMET PRIMARY TIBIAL TRAY 75MM WITH LOCKING BAR PROSTHESIS, KNEE MBH BIOMET ORTHOPEDICS N/A 295310

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R