BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD DA 360 KNEE SYSTEM ARCOM TIBIAL BEARING 63/67 X 18MM

    MDR report key: 6045470 · Received October 20, 2016

    Report

    Report Number
    0001825034-2016-04223
    Event Type
    Injury
    Date Received
    October 20, 2016
    Date of Event
    March 15, 2016
    Report Date
    February 1, 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

    EVENT DATE - (B)(6) 2016. MEDICAL PRODUCT - FEMORAL IMPLANT COMPONENT CATALOG# 185268, LOT # 277913, FEMORAL STEM CATALOG # 145024, LOT # 793510, FEMORAL AUGMENT COMPONENTS, CATALOG # 185348, 185348, 185308 LOT # 157630, 157360, 030310, TIBIAL TRAY CATALOG# 161429, LOT # 3457952, TIBIAL STEM CATALOG # 145022 LOT # 896220, TIBIAL AUGMENTS CATALOG # 185232, 185232, LOT# 409170, 409170.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. (B)(4). THIS PRODUCT IS NOT CLEARED FOR DISTRIBUTION 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 K093293.

    Description of Event or Problem · 1

    PATIENT REPORTED RIGHT KNEE IMPLANT "FEELS LIKE IT HAS MOVED" AND REPORTED A "CLUNK" FEELING. THE PATIENT WAS TREATED WITH A KNEE BRACE. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694889 VANGUARD DA 360 KNEE SYSTEM ARCOM TIBIAL BEARING 63/67 X 18MM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 3428061

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention