BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD XP FEMORAL COMPONENT

    MDR report key: 8038658 · Received November 5, 2018

    Report

    Report Number
    0001825034-2018-10213
    Event Type
    Injury
    Date Received
    November 5, 2018
    Date of Event
    July 1, 2019
    Report Date
    August 25, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBH
    PMA / PMN Number
    K141407
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS : VANGUARD XP TIBIAL TRAY CAT#:195753, LOT#: 467170 , VANGUARD XP TIBIAL BEARING RL CAT#:195772, LOT#: 924610, VANGUARD XP TIBIAL BEARING RM CAT#: 195843, LOT#: 755650. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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 · 0

    THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED: B4, B5, D7, E1, G4, G7, H1, H2, H6, AND H10 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 · 0

    MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT: 0001825034-2018-10242 0001825034-2018-10243 0001825034-2019-03201 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

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN NINE (9) MONTHS AFTER INITIAL RIGHT KNEE ARTHROPLASTY.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PARTIAL REVISION PROCEDURE DUE TO UNKNOWN REASONS. THERE IS NO ADDITIONAL INFORMATION AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). CONCOMITANT MEDICAL PRODUCTS: VANGUARD XP TIBIAL TRAY, CAT#:195753, LOT#: 467170. VANGUARD XP TIBIAL BEARING, CAT#:195772, LOT#: 924610. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT REMAINS IMPLANTED. 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: 0001825034-2018-10242, 0001825034-2018-10243.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN TWO MONTHS AFTER INITIAL RIGHT KNEE ARTHROPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    880494 VANGUARD XP FEMORAL COMPONENT PROSTHESIS, KNEE MBH ZIMMER BIOMET, INC. N/A 029380

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R SEE H10.