BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD DUAL ARTICULATING (DA) BEARING 71/75 X 16 MM

    MDR report key: 6303841 · Received February 6, 2017

    Report

    Report Number
    3002806535-2017-00056
    Event Type
    Injury
    Date Received
    February 6, 2017
    Date of Event
    January 10, 2017
    Report Date
    October 14, 2017
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JWH
    PMA / PMN Number
    PNA
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURE DATE UPDATED TO OCT 20, 2014.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: BIOMET SMOOTH KNEE STEM 16X80, PART NUMBER: 145026, LOT NUMBER: 470050. BIOMET SMOOTH KNEE STEM 14X80, PART NUMBER :145024, LOT NUMBER: 316550. VANGUARD DUAL ARTICULATING 360 O/S TIBIAL TRAY, PART NUMBER: 161431, LOT NUMBER: 3535584. VANGUARD SSK 360 LEFT FEMORAL 65 MM, PART NUMBER: 185284, LOT NUMBER: 3603059. 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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPON RECEIPT OF ADDITIONAL INFORMATION, THIS REPORT WILL BE COMPLETED UNDER MANUFACTURING REPORT NUMBER 0001825034-2017-08428.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION(S) IS/ARE REQUIRED. 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 HAS BEEN REPORTED THAT FOLLOWING A TOTAL KNEE ARTHROPLASTY, THE PATIENT UNDERWENT A POLYETHYLENE REVISION DUE TO DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87639 VANGUARD DUAL ARTICULATING (DA) BEARING 71/75 X 16 MM PROSTHESIS, KNEE JWH BIOMET UK LTD. N/A 3407779

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R