BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD COMPLETE KNEE SYSTEM-FEMORAL COMPONENT

    MDR report key: 6531881 · Received April 28, 2017

    Report

    Report Number
    0001825034-2017-02924
    Event Type
    Injury
    Date Received
    April 28, 2017
    Report Date
    November 1, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK113550
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: BIOMET TIBIAL TRAY, CATALOG 141223, LOT J100917050; SERIES A PATELLA CATALOG 184764, LOT 547560; VANGUARD TIBIAL BEARING, CATALOG 183644, LOT 169590. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE PROSTHESIS CURRENTLY REMAINS IN SITU. 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: 1825034-2017-02945, 1825034-2017-02946, 1825034-2017-02947.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    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. DHR WAS REVIEWED AND NO DISCREPANCIES 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.

    Description of Event or Problem · 1

    PATIENT HAS BEEN INDICATED FOR A RIGHT KNEE REVISION PROCEDURE DUE TO PAIN, LIMITED MOBILITY, PINCHING, AND BURNING. NO REVISION HAS BEEN REPORTED TO DATE. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    PATIENT HAS BEEN INDICATED FOR A RIGHT KNEE REVISION PROCEDURE DUE TO PAIN, LIMITED MOBILITY, PINCHING, AND BURNING. NO REVISION HAS BEEN REPORTED TO DATE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT IS UNDERGOING INTENSIVE CORE STRENGTHENING THERAPY. THE PATIENT'S KNEE IS STILL EXPERIENCING THE REPORTED ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311775 VANGUARD COMPLETE KNEE SYSTEM-FEMORAL COMPONENT PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS 633140

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention