BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD DA 360 TIBIAL BEARING ARCOM 63/67X18

    MDR report key: 6632230 · Received June 9, 2017

    Report

    Report Number
    3002806535-2017-00482
    Event Type
    Injury
    Date Received
    June 9, 2017
    Date of Event
    November 26, 2016
    Report Date
    November 10, 2017
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). (B)(4). CONCOMITANT MEDICAL DEVICES: BIOMET SMOOTH KNEE STEM 14X80, ITEM # 145024, LOT # 934030. VANGUARD DA 360 O/S TIBIAL TRAY COCR 67, ITEM # 161429, LOT # 3582208. BIOMET SMOOTH KNEE STEM 12X40, ITEM # 145002, LOT # 378490. BIOMET 360 OFFSET ADAPTER 2.5MM, ITEM # 185210, LOT # 827040. VANGUARD DA 360 TIBIAL BEARING ARCOM 63/67X18, ITEM # 161443, LOT # 3217590. (B)(6). 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. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION DUE TO THE DEVICE REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS HAVE BEEN FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2017-00480, 0001825034-2017-03816, 3002806535-2017-00481, 0001825034-2017-03818, 0001825034-2017-03819.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. (B)(4). 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 AS NO WERE TRENDS 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 THAT THE PATIENT UNDERWENT A KNEE ASPIRATION AS WELL AS AN EXAM UNDER ANESTHESIA APPROXIMATELY TEN MONTHS POST IMPLANTATION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410625 VANGUARD DA 360 TIBIAL BEARING ARCOM 63/67X18 PROSTHESIS, KNEE JWH BIOMET UK LTD. 3217590

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R