BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGAURD SSK INTERLOCKING FEMORAL

    MDR report key: 7756660 · Received August 7, 2018

    Report

    Report Number
    0001825034-2018-05353
    Event Type
    Injury
    Date Received
    August 7, 2018
    Date of Event
    March 8, 2018
    Report Date
    April 3, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK042757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT WAS CONFIRMED VIA X-RAYS. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. X-RAYS INDICATE ALL COMPONENTS IN PROPER POSITION HOWEVER THERE IS A FAILED SCREW. OPERATIVE FINDING INDICATE THE SCREW FAILED WITHOUT OBVIOUS BREAKAGE. 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 · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT: CATALOG #: 141491, OFFSET TIBIAL TRAY, LOT # 831250. CATALOG #: 141762, BIOMET TIBIAL BLOCK, LOT # 008840. CATALOG #: 141762, BIOMET TIBIAL BLOCK, LOT # 262340. CATALOG #: 185022, VANGUARD SSK TIBIAL BEARING, LOT # 600890. CATALOG #: 184122, VANGUARD DISTAL FEMORAL AUGMENT, LOT # 733060. CATALOG #: 184102, VANGUARD DISTAL FEMORAL AUGMENT, LOT # 287050. CATALOG #: 183322, VANGUARD SSK INTERLOCKING FEMORAL, LOT # 538890. CATALOG #: 141652, BIOMET SPLINED KNEE STEM, LOT # 664880. CATALOG #: 141612, BIOMET SPLINED KNEE STEM, LOT # 736620. THE CUSTOMER HAS NOT INDICATED WHETHER THE PRODUCT WILL BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION OR NOT. ONCE THIS INFORMATION IS OBTAINED 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.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 VIA THE MEDICAL RECORDS FROM LEGAL COUNSEL THAT THE PATIENT FELT A POP AND INCREASED PAIN. SUBSEQUENTLY THEY HAD A REVISION DUE TO THE FAILURE OF THE LOCKING SCREW FOR THE FEMORAL COMPONENT AND STEM APPROXIMATELY 4 MONTHS AGO. THERE WAS NO POLY DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600818 VANGAURD SSK INTERLOCKING FEMORAL PROSTHESIS KNEE JWH ZIMMER BIOMET, INC. N/A 538890

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention