BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VG DA 360 O/S TIB TRAY COCR 71

    MDR report key: 5692379 · Received June 1, 2016

    Report

    Report Number
    0001825034-2016-01861
    Event Type
    Injury
    Date Received
    June 1, 2016
    Date of Event
    May 29, 2015
    Report Date
    June 2, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PNA
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. THE FOLLOWING COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. EXPIRATION DATE - NI. MANUFACTURE DATE ¿ NI. (B)(6). THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN (B)(4) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K093293. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 3 STATES, "INTRAOPERATIVE BONE PERFORATION OR FRACTURE MAY OCCUR, PARTICULARLY IN THE PRESENCE OF POOR BONE STOCK CAUSED BY OSTEOPOROSIS, BONE DEFECTS FROM PREVIOUS SURGERY, BONE RESORPTION, OR WHILE INSERTING THE DEVICE." THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-01860 / 01861). REMAINS IMPLANTED.

    Description of Event or Problem · 1

    DURING A LEFT KNEE REVISION PROCEDURE, THE PATIENT'S TIBIA FRACTURED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345296 VG DA 360 O/S TIB TRAY COCR 71 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 2441002

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention