BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VAN PS OPEN INTL FEM-LT 70 70

    MDR report key: 11677310 · Received April 16, 2021

    Report

    Report Number
    0001825034-2021-01109
    Event Type
    Injury
    Date Received
    April 16, 2021
    Date of Event
    March 29, 2021
    Report Date
    April 15, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00880304270923
    PMA / PMN Number
    K113550
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG#: 183760 VNGD PS+ TIB BRG 10X79/83MM, LOT#: 211910, CATALOG#: 185651 BMT 360 TIB LG CRUCIATE WING, LOT#: 460900, CATALOG#: 185205 BMT 360 TIB TRAY 79MM, LOT#: 057110, CATALOG#: 148303 BMT SPLINED KNEE STM V2 13X80 80, LOT#: 665260, CATALOG#: 185235 BMT 360 TIB AUG 79X10MM MM, LOT#: 354800. THE EVENT IS CONFIRMED WITH X-RAYS RECEIVED. REVIEW OF THE X-RAYS FOUND LOOSE FEMORAL IMPLANT THAT HAS MALROTATED WITH MALALIGNMENT. BONE QUALITY IS OSTEOPENIC. THERE APPEARS TO BE A PAUCITY OF FEMORAL FIXATION CEMENT WHICH COULD CONTRIBUTE TO FEMORAL IMPLANT LOOSENING. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. 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 · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 2 YEARS AND 4 MONTHS POST IMPLANTATION DUE TO FEMUR LOOSENING. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575094 VAN PS OPEN INTL FEM-LT 70 70 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A J3910886 00880304270923

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R