BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD LOCKING BAR COMPONENT

    MDR report key: 8796690 · Received July 16, 2019

    Report

    Report Number
    0001825034-2019-03046
    Event Type
    Injury
    Date Received
    July 16, 2019
    Report Date
    December 13, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY UPDATED AND ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. VISUAL EXAMINATION OF THE RETURNED LOCKING BAR FOUND HEAVY NICK MARKS AND LIGHT SCRATCHES AND SHINY SPOTS. THE LOCKING BAR WAS SUBMITTED FOR FURTHER ANALYSIS. ANALYSIS DETERMINED THAT THE CONTACT ARTIFACTS ON THE SUPERIOR SURFACE OF THE LOCKING BAR INDICATE THAT IT MAY HAVE NOT BEEN FULLY ENGAGED. IN ADDITION, THE CLASP CONTACT SURFACE DOES NOT SHOW SIGNIFICANT CONTACT ARTIFACTS. HOWEVER, THERE IS INSUFFICIENT INFORMATION TO DETERMINE WHETHER THE REPORTED LOCKING BAR DISSOCIATION OCCURRED DUE TO IMPROPER INSERTION. 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. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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 · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). CONCOMITANT MEDICAL PRODUCTS: VGXP XP E1 TIB BRG; P/N: 195815, L/N: 822870, KNE-VANGUARD-LOCKING BAR-UNK; P/N: UNK, L/N: UNK. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2019 - 03045, 0001825034 - 2019 - 03046.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT HAD A REVISION ON AN UNKNOWN DATE DUE TO THE LOCKING BAR BACKING OUT OF TIBIA AND THE LATERAL BEARINGS DISLOCATING. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590277 VANGUARD LOCKING BAR COMPONENT PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R