BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD KNEE SYSTEM PS TIBIAL BEARING

    MDR report key: 6977804 · Received October 25, 2017

    Report

    Report Number
    0001825034-2017-09669
    Event Type
    Injury
    Date Received
    October 25, 2017
    Report Date
    November 21, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK080528
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    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. REVIEW OF THE DEVICE HISTORY RECORD FOUND THAT EIGHT PIECES WERE REWORKED TO HAVE EXCESS SCRATCHING ON THE FLAT. 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 · 0

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

    Additional Manufacturer Narrative · 1

    MEDICAL PRODUCTS: VANGUARD FINNED TIBIAL TRAY, CATALOG #: 141253, LOT #: 2016021853; ANGUARD POSTERIOR STABILIZED FEMORAL, CATALOG #: 183126, LOT #: J3688009. 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 - UNKNOWN VANGUARD FEMUR , UNKNOWN VANGUARD TIBIAL TRAY . FOREIGN: COUNTRY IS UNKNOWN AT THIS TIME. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A MANIPULATION UNDER ANAESTHESIA 1 MONTH POST INITIAL SURGERY. 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
    756335 VANGUARD KNEE SYSTEM PS TIBIAL BEARING PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 522340

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R