BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD DA360 TIBIAL BEARING

    MDR report key: 6866727 · Received September 14, 2017

    Report

    Report Number
    0001825034-2017-07118
    Event Type
    Injury
    Date Received
    September 14, 2017
    Date of Event
    June 7, 2017
    Report Date
    November 3, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PSEE H10
    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

    (B)(4). MEDICAL PRODUCT: BIOMET 360 OFFSET ADAPTER, CAT#: 185210 LOT#: 827040; BIOMET SMOOTH KNEE STEM, CAT#: 145002 LOT#: 378490; VANGUARD 360 FEMORAL, CAT#: 185265 LOT#: 3636273; VANGUARD 360 TIBIAL TRAY, CAT#: 161429 LOT#: 3582208; BIOMET SMOOTH KNEE STEM, CAT#: 145024 LOT#: 934030. THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET (B)(4) MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K093293. 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. PRODUCT LOCATION UNKNOWN.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY THIS REPORT IS A DUPLICATE OF 3002806535-2017-00064.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED TO ADDRESS INSTABILITY AND STIFFNESS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644188 VANGUARD DA360 TIBIAL BEARING PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 3217590

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R