BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD 360 REVISION SYSTEM SSK/DA 360 DISTAL FEMORAL AUGMENT

    MDR report key: 8455846 · Received March 27, 2019

    Report

    Report Number
    0001825034-2019-01404
    Event Type
    Injury
    Date Received
    March 27, 2019
    Date of Event
    December 19, 2018
    Report Date
    December 12, 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
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THIS COMPLAINT WAS NOT CONFIRMED. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. THE MEDICAL RECORDS PROVIDED WERE NOT FURTHER REVIEWED BY THE NURSING TEAM AS THEY CONTAINED MINIMAL INFORMATION. ADDITIONAL MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE 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). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT HAS BEEN DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: ITEM # 185264, LOT # 2924013, VANGUARD SSK 360 FEMORAL WITH SCREW. ITEM # 185344, LOT # 088920, VANGUARD 360 POSTERIOR AUGMENT 65MM WITH BOLT. ITEM # 185384, LOT # 002180, VANGUARD 360 DISTAL FEMORAL AUGMENT 10MM X 65MM WITH BOLT. ITEM # 148307, LOT # 877190, SPLINED KNEE SYSTEM V2 17MM X 80MM. ITEM # 185210, LOT # 524220, 360 OFFSET ADAPTOR 2.5MM WITH SCREWS. ITEM # 185203, LOT # 289980, 360 TIBIAL TRAY WITH TI LOCKING BAR AND SCREW 71MM. ITEM # 148287, LOT # 795740, SPLINED KNEE SYSTEM V2 12MM X 40MM. ITEM # 185212, LOT # 902910, 360 OFFSET ADAPTOR 7.5MM WITH SCREWS. ITEM # 185551, LOT # 058470, VANGUARD 360 OSSEOTI TIBIAL SLEEVE AUGMENT . ITEM # 183880, LOT # 911630, VANGUARD DCM TIBIAL BEARING 10MM X 71 75 MM. STRYKER SIMPLEX BONE CEMENT. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT; PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-01403, 0001825034-2019-01405, 0001825034-2019-01406, 0001825034-2019-01407, 0001825034-2019-01408, 0001825034-2019-01412, 0001825034-2019-01413, 0001825034-2019-01414, 0001825034-2019-01415, 0001825034-2019-01416. 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 THAT A PATIENT UNDERWENT AN INITIAL KNEE PROCEDURE AND THREE YEARS AFTER THE PROCEDURE THE PATIENT WAS REVISED DUE TO INSTABILITY AND LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250338 VANGUARD 360 REVISION SYSTEM SSK/DA 360 DISTAL FEMORAL AUGMENT PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 346730

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R