BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD DUAL ARTICULATING (DA) BEARING 71/75 X 16 MM

    MDR report key: 6025471 · Received October 13, 2016

    Report

    Report Number
    0001825034-2016-04102
    Event Type
    Injury
    Date Received
    October 13, 2016
    Date of Event
    September 15, 2016
    Report Date
    March 22, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS USER FACILITY IS OUTSIDE OF THE UNITED STATES. THE NECESSARY MANUFACTURING HISTORY TO REVIEW WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. PATIENT WAS BORN ON AN UNKNOWN DATE IN 1953. THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET IN (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S., HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN (B)(4) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K042757.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT DEVICES: VANGUARD SSK 360 L FEMORAL 70 MM CATALOG #: 185286 LOT #: 3269944, FEMORAL SMOOTH STEM 18 X 80 MM CATALOG #: 145028 LOT #: 833010, VANGUARD 360 UNIVERSAL POSTERIOR FEMORAL AUGMENT 70 X 5 CATALOG #: 185346 LOT#: 800350, VANGUARD 360 UNIVERSAL POSTERIOR FEMORAL AUGMENT 70 X 5 CATALOG #: 185346 LOT#: 665530, VANGUARD 360 UNIVERSAL POSTERIOR FEMORAL AUGMENT 70 X 10 CATALOG #: 185406 LOT#: 874290, VANGUARD 360 TIBIAL TRAY CATALOG #: 161431 LOT #: 3194727, BIOMET SMOOTH KNEE STEM 14 X 40 MM #: 145004 LOT#: 674920, BIOMET 360 TIBIAL 5.0 OFFSET ADAPTER #: 185211 LOT #: 817970. (B)(4). 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 AS NO WERE TRENDS IDENTIFIED. 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

    A PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT AN ASPIRATION OF THE LEFT KNEE DUE TO PAIN AND SWELLING APPROXIMATELY SIX MONTHS POST TOTAL KNEE ARTHROPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678591 VANGUARD DUAL ARTICULATING (DA) BEARING 71/75 X 16 MM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 3390532

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention