BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD SSK 360 LEFT FEMORAL

    MDR report key: 9590694 · Received January 15, 2020

    Report

    Report Number
    0001825034-2020-00249
    Event Type
    Injury
    Date Received
    January 15, 2020
    Date of Event
    November 12, 2019
    Report Date
    April 16, 2020
    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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. 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 REPORT 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

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). MEDICAL PRODUCTS: VNGD SSK PSC FMRL STEM SCREW; P/N: 183315, L/N: UNK, BMT SPLINED KNEE STM V2 14X80; P/N: 148304, L/N: 274090, BMT SPLINED KNEE STM V2 17X120; P/N: 148320, L/N: 461260, VNGD SSK PSC TIB BRG 12X79/83; P/N: 183902, L/N: 003130, SERIES A PAT STD 34 3 PEG; P/N: 184766, L/N: 458910, BMT 360 TIB TRAY 83MM; P/N: 185206, L/N: 096930, BMT 360 TIB 5.0 OFFSET ADAPTER; P/N: 185211, L/N: 691210, VNGD SSK 360 L FEM 70MM; P/N: 185286, L/N: 3782952, BMT 360 TIB SM CRUCIATE WING; P/N: 185650, L/N: 920110. CUSTOMER HAS NOT 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2019 - 05452 - 1. PRODUCT LOCATION IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A REVISION PROCEDURE 3 YEARS POST-IMPLANTATION DUE TO SCREW BACKING OUT OF THE FEMORAL COMPONENT. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54453 VANGUARD SSK 360 LEFT FEMORAL PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 3782952

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R