BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNGD CR TIB BRG 10X71/75

    MDR report key: 6907787 · Received October 2, 2017

    Report

    Report Number
    0001825034-2017-07650
    Event Type
    Injury
    Date Received
    October 2, 2017
    Date of Event
    June 12, 2014
    Report Date
    September 29, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK023546
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. INCONCLUSIVE-ROOT CAUSE CANNOT BE DETERMINED. CONDITION IS ADDRESSED IN THE PACKAGE INSERT. REVIEW OF DEVICE HISTORY RECORDS FOUND THIS PART WAS RELEASED TO DISTRIBUTION WITH NO DEVIATIONS OR ANOMALIES. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL ISSUES REPORTED FOR THIS PART. RELAYED RESULTS VIA EMAIL TO BIOMET (B)(6) ON (B)(6) 2014. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL ISSUES REPORTED FOR ITEM: 183440 LOT: 942370 COMBINATION. 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 A PATIENT UNDERWENT VANGUARD KNEE SURGERY ON (B)(6) 2011. REVISED 1 PC TIBIAL TRAY AND VANGUARD CR CURV ON (B)(6) 2014 DUE TO LOOSENING CAUSED BY PATIENT JUMPING OFF A TRUCK. REPLACED WITH VANGUARD 360 COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686564 VNGD CR TIB BRG 10X71/75 PROSTHESIS- KNEE JWH ZIMMER BIOMET, INC. N/A 942370

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R