BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD XP RIGHT MEDIAL TIBIAL BEARING

    MDR report key: 6908435 · Received October 2, 2017

    Report

    Report Number
    0001825034-2017-07348
    Event Type
    Injury
    Date Received
    October 2, 2017
    Date of Event
    August 30, 2017
    Report Date
    November 28, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBH
    PMA / PMN Number
    PK122160
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE REPORTED EVENT COULD NOT BE CONFIRMED AS THE PRODUCT WAS NOT RETURNED, NO VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE INFORMATION PROVIDED WAS LIMITED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: VANGUARD XP FEMORAL INTERLOK WITH PEGS, CAT#: 195205, LOT#: 853540; VANGUARD XP TIBIAL TRAY, CAT#: 195250, LOT#: 833210; VANGUARD XP RIGHT LATERAL TIBIAL BEARING, CAT#: 195333, LOT#: 515060. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-07345, 0001825034-2017-07346, 0001825034-2017-07347. PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED TO ADDRESS ADHESIONS, APPROXIMATELY FOUR YEARS POST INITIAL IMPLANTATION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688752 VANGUARD XP RIGHT MEDIAL TIBIAL BEARING PROSTHESIS, KNEE MBH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R