BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD XP TIBIAL BEARING RIGHT LATERAL

    MDR report key: 6921817 · Received October 6, 2017

    Report

    Report Number
    0001825034-2017-07820
    Event Type
    Injury
    Date Received
    October 6, 2017
    Date of Event
    April 3, 2015
    Report Date
    October 21, 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

    (B)(4). CONCOMITANT MEDICAL PRODUCTS - VANGUARD XP INTERLOK FEMORAL #195203 LOT #990310, VANGUARD XP INTERLOK PRI TIBIAL TRAY #195249 LOT#837770 AND VANGUARD XP TIBIAL BEARING RIGHT MEDIAL #195402 LOT #946150. (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: VANGUARD XP TIBIAL BEARING RIGHT MEDIAL - 0001825034-2017-07821. IT IS UNKNOWN IF PRODUCT WILL BE RETURNING TO ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES 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 NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT 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 A BEARING REVISION AND SCAR RESECTION APPROXIMATELY 1 YEAR POST INITIAL KNEE SURGERY. NO COMPLICATIONS OR DELAYS WERE REPORTED. 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
    703422 VANGUARD XP TIBIAL BEARING RIGHT LATERAL PROSTHESIS KNEE MBH ZIMMER BIOMET, INC. N/A 052270

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R