BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD XP FEMORAL LEFT WITH PEGS

    MDR report key: 7167246 · Received January 5, 2018

    Report

    Report Number
    0001825034-2018-00077
    Event Type
    Injury
    Date Received
    January 5, 2018
    Date of Event
    November 23, 2017
    Report Date
    March 6, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBH
    PMA / PMN Number
    PK141407
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). CONCOMITANT MEDICAL PRODUCTS: VANGUARD XP-XP TIBIAL TRAY INTERLOK CAT#: 195754, LOT#: 181410. VANGUARD XP-XP LEFT LATERAL BEARING CAT#: 195816 LOT#: 659560. VANGUARD XP-XP LEFT MEDIAL BEARING CAT#: 195887, LOT#:053250. 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: 0001825034-2018-00078, 0001825034-2018-00079, 0001825034-2018-00080.

    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. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED . 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 WAS REVISED ONE YEAR AFTER INITIAL SURGERY DUE TO GLOBAL LAXITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12372 VANGUARD XP FEMORAL LEFT WITH PEGS PROSTHESIS, KNEE MBH ZIMMER BIOMET, INC. N/A 439760

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R