BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD TIBIAL BEARING

    MDR report key: 7151612 · Received December 28, 2017

    Report

    Report Number
    0001825034-2017-11428
    Event Type
    Injury
    Date Received
    December 28, 2017
    Report Date
    March 2, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK113550
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS INITIALLY REPORTED UNDER MANUFACTURING REPORT NUMBER: 0001822565-2017-04546. (B)(4). ADDITIONAL CONCOMITANT MEDICAL PRODUCTS: VANGUARD INTERLOK FEMORAL, CATALOG #: 183202 LOT #: 149220; BIOMET CRUCIATE TRAY, CATALOG #: 141233 LOT #: J3811794; BIOMET ARCOM PATELLA, CATALOG #: 11-150826 LOT #: 230530. 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: 0001825034-2017-11423, 0001825034-2017-11427, 0001825034-2017-11428, 0001825034-2017-11429. REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    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 IS SUFFERING FROM PAIN AND SWELLING IN THE KNEE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    930735 VANGUARD TIBIAL BEARING PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 349520

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R