BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNGD CR TIB BRG 10X71/75

    MDR report key: 7762458 · Received August 8, 2018

    Report

    Report Number
    0001825034-2018-06728
    Event Type
    Injury
    Date Received
    August 8, 2018
    Date of Event
    September 29, 2004
    Report Date
    October 8, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK113550
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS - VANGUARD CR ILOK FEM-RT 65, CAT#: 1830058 LOT#: NI, BIOMET CC I-BEAM TRAY 71MM, CAT#: 141223 LOT#: NI, KNE-BIOMET ARCOM-PATELLAS-UNK SIZE 31, CAT#: NI LOT#: NI. PRODUCT IS CURRENTLY NOT EXPECTED TO RETURN TO ZIMMER BIOMET FOR INVESTIGATION AS IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED WITH THE INFORMATION PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN IRRIGATION AND DEBRIDEMENT OF THE TIBIAL BEARING DUE TO WOUND DEHISCENCE APPROXIMATELY 8 DAYS POST-IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602943 VNGD CR TIB BRG 10X71/75 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R