BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD SSK FEMORAL COMPONENT

    MDR report key: 7799143 · Received August 20, 2018

    Report

    Report Number
    0001825034-2018-08289
    Event Type
    Injury
    Date Received
    August 20, 2018
    Date of Event
    July 17, 2018
    Report Date
    June 20, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K093293
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UDI- (B)(4). CONCOMITANT MEDICAL PRODUCTS- BIOMET TAPER SCREW, CATALOG # 185213, LOT # 792540, BIOMET 360 TIBIAL CRUCIATE WING, CATALOG # 185650, LOT # 473500, BIOMET 360 TIBIAL OFFSET, CATALOG # 185211, LOT # 276390, BIOMET SPLINED KNEE STEM, CATALOG # 148302, LOT # 385050, BIOMET TIBIAL TRAY, CATALOG # 185202, LOT # 933680, BIOMET SPLINED KNEE STEM, CATALOG # 148305, LOT # 430260, VANGUARD 360 DISTAL FEMORAL AUGMENT, CATALOG # 185384, LOT # 409170, BIOMET 360 OFFSET ADAPTER, CATALOG # 185210, LOT # 014480, VANGUARD 360 DISTAL FEMORAL AUGMENT, CATALOG # 185404, LOT # 952350, VANGUARD SSK PS TIBIAL BEARING, CATALOG # 185064, LOT # 742510. REPORTED EVENT WAS CONFIRMED BY REVIEW OF RADIOGRAPHS. REVIEW OF THE X-RAYS BY A THIRD PARTY HCP STATE THAT THE DISLODGED SCREW IS SEEN IN THE INTERCONDYLAR NOTCH OF THE FEMUR. THE REMAINDER OF THE HARDWARE APPEARS INTACT AND NO PERIPROSTHETIC LUCENCY. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE CANNOT 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.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). OUR INVESTIGATION IS ONGOING. A FOLLOW-UP/FINAL REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. REQUESTED BUT HOSPITAL DOES NOT ALLOW.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE PATIENT UNDERWENT AN INITIAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO THE SCREW BACKING OUT OF THE FEMORAL COMPONENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638970 VANGUARD SSK FEMORAL COMPONENT PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. NI 3961552

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R