BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD 360 DST FEMORAL AUGMENT

    MDR report key: 8977232 · Received September 9, 2019

    Report

    Report Number
    0001825034-2019-04008
    Event Type
    Injury
    Date Received
    September 9, 2019
    Report Date
    January 2, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K093293
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY UPDATED AND ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). EVENT DATE - UNKNOWN DATE ON (B)(6) 2018. (B)(4). CONCOMITANT MEDICAL PRODUCTS: VNGD SSK 360 R FEM 65MM; P/N: 185264, L/N: 3514494, VG 360 DST FM AG 65X10 RL/LM; P/N: 185384, L/N: 333920, VG 360 UNIV PST FM AUG 65X10; P/N: 185424, L/N: 756220, VG 360 DST FM AG 65X10 LL/RM; P/N: 185404, L/N: 336980, BMT 360 TIB 5.0 OFFSET ADAPTER; P/N: 185211, L/N: 663200, BMT 360 TIB TRAY 67MM; P/N: 185202, L/N: 208810, BMT SPLINED KNEE STM V2 13X80; P/N: 148303, L/N: 877140, BMT SPLINED KNEE STM V2 15X40; P/N: 148290, L/N: 605010, BMT 360 2.5MM OFFSET ADAPTER; P/N: 185210, L/N: 012980, VG 360 OTI TIB SLV XS HALF B; P/N: 185535, L/N: 738480, VG 360 OTI TIB SLV MD HALF A; P/N: 185532, L/N: 883840, VNGD SSK PSC TIB BRG 14X63/67; P/N: 183864, L/N: 921080. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. 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 - 04007, 0001825034 - 2019 - 04008, 0001825034 - 2019 - 04009, 0001825034 - 2019 - 04010, 0001825034 - 2019 - 04011. PRODUCT LOCATION IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SUSTAINED A FALL APPROXIMATELY TWO YEARS POST IMPLANTATION. SUBSEQUENTLY, THE PATIENT SUFFERED A FRACTURED FEMUR, WHICH REQUIRED A REVISION PROCEDURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768363 VANGUARD 360 DST FEMORAL AUGMENT PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 333920

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R