BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD DA 360 TIBIAL TRAY

    MDR report key: 6526336 · Received April 27, 2017

    Report

    Report Number
    3002806535-2017-00260
    Event Type
    Injury
    Date Received
    April 27, 2017
    Date of Event
    March 2, 2017
    Report Date
    September 21, 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

    (B)(4). MEDICAL PRODUCT-UNKNOWN BEARING, VNGD SSK 360 L FEM 65 MM CATALOG# 185284 LOT# 3603059, BMT SMOOTH KNEE STEM 16 X 80 CATALOG# 145026 LOT# 470050, BMT SMOOTH KNEE STEM 14 X 80 CATALOG# 145024 LOT# 316550. REPORT SOURCE: (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 TO ZIMMER BIOMET FOR INVESTIGATION AS PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535 - 2017 - 00258, 3002806535 - 2017 - 00259, 0001825034 - 2017 - 02893, 0001825034 - 2017 - 02897.

    Additional Manufacturer Narrative · 1

    UPON REVIEW, IT HAS BEEN DETERMINED THAT THE DEVICE SHOULD NOT HAVE BEEN REPORTED UNDER THIS MFR NUMBER. THIS REPORT SHOULD BE VOIDED, AS A CORRECTED REPORT HAS BEEN FILED UNDER MFR NUMBER 0001825034-2017-07286.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND ASSOCIATED RISKS ARE ADDRESSED IN RISK DOCUMENTATION. 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 DEBRIDEMENT AND RECEIVED ANTIBIOTICS DUE TO INFECTION TWO MONTHS POST REVISION. ALL IMPLANTS WERE RETAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307214 VANGUARD DA 360 TIBIAL TRAY PROSTHESIS, KNEE JWH BIOMET UK LTD. 3535584

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R