BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 6304186 · Received February 6, 2017

    Report

    Report Number
    3002806535-2017-00064
    Event Type
    Injury
    Date Received
    February 6, 2017
    Report Date
    September 26, 2017
    Manufacturer
    BIOMET UK LTD.
    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

    PATIENT WAS BORN IN (B)(6). MEDICAL PRODUCT - VNGD SSK 360 FEMUR R 67.5 CATALOG# 185265 LOT# 3636273, BMT SMOOTH KNEE STEM 14X80 CATALOG# 145024 LOT# 934030, VG DA 360 O/S TIB TRAY COCR 67 CATALOG# 161429 LOT# 3582208, BIOMET SMOOTH KNEE STEMS 12X40 CATALOG# 145002 LOT# 378490, BMT 360 2.5MM OFFSET ADAPTER CATALOG# 185210 LOT# 827040, UNKNOWN PALACOS BONE CEMENT.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCT - VNGD SSK 360 FEMUR R 67.5, CATALOG# 185265, LOT# 3636273; BMT SMOOTH KNEE STEM 14X80, CATALOG# 145024 LOT# 934030; VG DA 360 O/S TIB TRAY COCR 67 CATALOG# 161429, LOT# 3582208; BIOMET SMOOTH KNEE STEMS 12X40 CATALOG# 145002, LOT# 378490; BMT 360 2.5MM OFFSET ADAPTER CATALOG# 185210, LOT# 827040. 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. EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH SINCE THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE MAY BE NECESSARY. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING A REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND, IF WARRANTED, FURTHER MEDWATCH REPORTS WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THIS EVENT WILL BE REPORTED ON 0001825034-2017-07359.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAS PLANNED A REVISION DUE TO INSTABILITY AND STIFFNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86778 VANGUARD DA 360 KNEE SYSTEM ARCOM TIBIAL BEARING 63/67 X 18MM PROSTHESIS, KNEE JWH BIOMET UK LTD. N/A 3217590

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R