BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNGD CR TIB BRG 12X71/75

    MDR report key: 6344152 · Received February 20, 2017

    Report

    Report Number
    0001825034-2017-00341
    Event Type
    Injury
    Date Received
    February 20, 2017
    Date of Event
    December 16, 2014
    Report Date
    January 26, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK080528
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION. 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.

    Additional Manufacturer Narrative · 1

    MEDICAL PRODUCT: ITEM: 141314, BIOMET FINNED PRI STEM 40MM, LOT: 000210; ITEM: 183030, VANGUARD CR ILOK FEM-LT 67.5, LOT: 452370; ITEM: 141274, BMET REGENX PRI TIB TRAY 75MM, LOT: 869520; ITEM: 11-150824, BMET ARCOM AP PATELLA 37MM, LOT: 2291750; ITEM: 3003940002, REFOBACIN BONE CEMENT R 2X40G, LOT: A350AJ2914. REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH ISO 11137-2.

    Additional Manufacturer Narrative · 1

    DEVICE 1 OF 2 REFERENCE MFR. REPORT: 0001825034-2017-00816.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED LESS THAN ONE MONTH POST-IMPLANTATION DUE TO INFECTION. THE BEARING WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125442 VNGD CR TIB BRG 12X71/75 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 947500

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R