BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD INTERLOK FEMORAL

    MDR report key: 7397913 · Received April 4, 2018

    Report

    Report Number
    0001825034-2018-02358
    Event Type
    Injury
    Date Received
    April 4, 2018
    Date of Event
    March 2, 2018
    Report Date
    December 17, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK141407
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY UPDATED AND ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL EXAMINATION OF THE LATERAL CONDYLE OF THE FEMUR IDENTIFIED CORRESPONDING MARKS CONSISTENT WITH THE FEMUR ARTICULATING ON THE TRAY. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-02357-2, 0001825034-2018-02359-2.

    Additional Manufacturer Narrative · 0

    THE FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: VANGUARD TIBIAL LOCKING BAR, CATALOG #: 195763, LOT #: 195754; VANGUARD TIBIAL BEARING, CATALOG #: 195849, LOT #: 783570; COBALT BONE CEMENT, CATALOG #: 402282, LOT #: 627610. 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 · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS FURTHER REPORTED THAT THE RIGHT EXTERNAL POLYETHYLENE BEARING WAS LOOSE.

    Additional Manufacturer Narrative · 1

    (B)(4). :CONCOMITANT MEDICAL PRODUCTS VANGUARD XP TIBIAL BEARING, CATALOG #: 195779, LOT #: 757560, VANGUARD INTERLOK TIBIAL TRAY, CATALOG #: 195754, LOT #: UNKNOWN, VANGUARD TIBIAL LOCKING BAR, CATALOG #: 195763, LOT #: 195754. REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-02357, 0001825034-2018-02358, 0001825034-2018-02359.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED TO ADDRESS PAIN AND INSTABILITY. DURING THE REVISION PROCEDURE, THE SURGEON NOTED THAT THE BEARING WAS FRACTURED AND THAT THERE WAS A SUBSTANTIAL AMOUNT OF METALLOSIS IN THE JOINT FROM THE LOCKING BAR COMING INTO CONTACT WITH THE FEMORAL COMPONENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240225 VANGUARD INTERLOK FEMORAL PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 516040

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R