BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD XP-XP RIGHT MEDIAL BEARING

    MDR report key: 7142039 · Received December 22, 2017

    Report

    Report Number
    0001825034-2017-11410
    Event Type
    Injury
    Date Received
    December 22, 2017
    Date of Event
    May 24, 2017
    Report Date
    January 18, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBH
    PMA / PMN Number
    PK132873
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN THE ASSOCIATED RISK DOCUMENTATION. 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). FOREIGN- (B)(4). MEDICAL PRODUCTS: VANGUARD XP-XP RIGHT MEDIAL BEARING CAT#: 195849, LOT#: 865300. VANGUARD XP-XP RIGHT LATERAL BEARING CAT#: 195779, LOT#: 822650. VGXP INTLK FEMORAL RT 70 CAT#: 195779, LOT#: 029450. VGXP XP INLK PRI TIB TRAY 75MM CAT#: 195757, LOT#: 023400. 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 - 2017 - 11410, 0001825034 - 2017 - 11411. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN, SWELLING AND STIFFNESS ONE MONTH AFTER INITIAL RIGHT KNEE ARTHROPLASTY. PATIENT WAS SUBSEQUENTLY TREATED WITH MANIPULATION UNDER ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    921354 VANGUARD XP-XP RIGHT MEDIAL BEARING PROSTHESIS, KNEE MBH ZIMMER BIOMET, INC. N/A 865300

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R