BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD SSK FEMORAL

    MDR report key: 8313097 · Received February 6, 2019

    Report

    Report Number
    0001825034-2019-00483
    Event Type
    Injury
    Date Received
    February 6, 2019
    Report Date
    November 20, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UDI #: (B)(4). COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL EVALUATION OF THE RETURNED DEVICE SHOWS SIGNS OF WEAR. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. X-RAY REVIEW INDICATES THERE IS POSSIBLE LOOSENING OF THE TIBIAL COMPONENT AS WELL AS A SCREW IS SEEN DISASSEMBLED WITHIN THE INTRACONDYLAR NOTCH. THE CONTACT WAS SENT THE INVESTIGATION RESULTS. 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 · 0

    CONCOMITANT MEDICAL PRODUCTS: VNGD SSK PS TIB BRG 16X71/75 CATALOG # 185086 LOT # 056860, UNKNOWN LOCKING BAR CATALOG # UNKNOWN LOT # UNKNOWN, VG 360 DST FM AG 70X5 LL/RM CATALOG # 185326 LOT # 073090, VG 360 DST FM AG 70X10 RL/LM CATALOG # 185386 LOT # 554590, BMT 360 TIB TRAY 71MM CATALOG # 185203 LOT # 954960, BMT 360 TIB 5.0 OFFSET ADAPTER CATALOG # 185211 LOT # 232110, BMT 360 TIB SM CRUCIATE WING CATALOG # 185650 LOT # 535420, BMT SPLINED KNEE STM 12X80 CATALOG # 141612 LOT # 679120, BMT SPLINED KNEE STM 16X80 CATALOG # 141616 LOT # 169780, BMT 360 TIB 5.0 OFFSET ADAPTER CATALOG # 185211 LOT # 927980. THE COMPLAINT DEVICE HAS BEEN RETURNED, BUT THE DEVICE INVESTIGATION HAS NOT YET BEEN COMPLETED. ONCE THE EVALUATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    FROM ADDITIONAL INFORMATION RECEIVED, THE PATIENT WAS REVISED DUE TO LOOSENING IN KNEE.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: UNKNOWN VANGUARD TIBIAL COMPONENT CATALOG # UNKNOWN LOT # UNKNOWN, UNKNOWN VANGUARD ARTICULAR SURFACE CATALOG # UNKNOWN LOT # UNKNOWN. (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILLED FOR THIS EVENT: 0001825034-2019-00484. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS EXPERIENCING LOOSENING IN KNEE. NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE. ATTEMPT FOR FURTHER INFORMATION HAS BEEN MADE, BUT NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103517 VANGUARD SSK FEMORAL PROSTHESIS KNEE JWH ZIMMER BIOMET, INC. N/A 2616174

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention