BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD DA 360 TIBIAL BEARING ARCM 71/75X16

    MDR report key: 6530468 · Received April 28, 2017

    Report

    Report Number
    3002806535-2017-00265
    Event Type
    Injury
    Date Received
    April 28, 2017
    Date of Event
    March 8, 2017
    Report Date
    August 11, 2017
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). 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. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED AS IT REMAINS IMPLANTED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. (B)(6).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    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. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE 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

    IT WAS REPORTED A PATIENT WHO UNDERWENT A PARTIAL LEFT KNEE ARTHROPLASTY APPROXIMATELY 2 YEARS AGO HAS BEEN EXPERIENCING PAIN AND INSTABILITY. NO REVISION HAS BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311730 VANGUARD DA 360 TIBIAL BEARING ARCM 71/75X16 PROSTHESIS, KNEE JWH BIOMET UK LTD. 3390532

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention 360 TIBIAL OFFSET ADAPTER, ITEM 185211, LOT 817970| SMOOTH KNEE STEM 14X40, ITEM 145004, LOT 674920| SMOOTH KNEE STEM 18X80, ITEM 145028, LOT 833010| VANGUARD 360 FEMUR AUG, ITEM 185346, LOT 800350| VANGUARD 360 FEMUR AUG, ITEM 185406, LOT 874290| VANGUARD FEMUR AUG, ITEM 185346, LOT 665530| VANGUARD SSK 360 FEMUR, ITEM 185286, LOT 3269944