BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 6897958 · Received September 27, 2017

    Report

    Report Number
    0001825034-2017-07359
    Event Type
    Injury
    Date Received
    September 27, 2017
    Date of Event
    June 7, 2017
    Report Date
    November 9, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. IT WAS PREVIOUSLY REPORTED THE PRODUCT WAS RETURNED, THE PRODUCT WAS NOT RETURNED. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN THE ASSOCIATED RISK DOCUMENTATION. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE INFORMATION PROVIDED ON THIS FORM WAS PREVIOUSLY SUBMITTED UNDER MANUFACTURING REPORT NUMBER 3002806535-2017-00064. (B)(4). 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 12 X 40 CATALOG# 145002 LOT# 378490, BMT 360 2.5 MM OFFSET ADAPTER CATALOG# 185210 LOT# 827040. THERAPY DATE - NI. (B)(6). THE COMPLAINT DEVICE HAS BEEN RETURNED, BUT THE DEVICE INVESTIGATION HAS NOT YET BEEN COMPLETED. ONCE THE EVALUATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED 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. 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 THAT A PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION DUE TO STIFFNESS AND INSTABILITY.

    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
    676933 VANGUARD 360 KNEE SYSTEM ARCOM TIBIAL BEARING 63/67 X 18MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 3217590

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R