BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD SSK PS TIBIAL BEARING

    MDR report key: 8749542 · Received July 1, 2019

    Report

    Report Number
    0001825034-2019-02825
    Event Type
    Injury
    Date Received
    July 1, 2019
    Date of Event
    May 1, 2018
    Report Date
    September 24, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HRY
    PMA / PMN Number
    K171054
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE WAS NOT RETURNED. 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. MEDICAL RECORDS REVIEW INDICATES THAT THE PATIENT SUSTAINED A FALL DUE TO UNKNOWN REASONS. SINCE THE REASON IS UNKNOWN, THE DEVICE CANNOT BE RULED OUT AS THE CAUSE OF THE FALL. HOWEVER, NO INJURY TO PATIENT OR DEVICE WAS NOTED, AND THERE IS NO REPORT OF INTERVENTION FOR TREATMENT. 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). CONCOMITANT MEDICAL PRODUCT: VANGUARD SSK FEMUR CATALOG # 185265, LOT # 3346324. VANGUARD DISTAL FEMORAL AUGMENT CATALOG # 185305, LOT # 441240. VANGUARD DISTAL FEMORAL AUGMENT CATALOG # 185325, LOT # 640430. BIOMET SPLINED KNEE STEM CATALOG # 141618, LOT # 021100. BIOMET TIBIAL TRAY CATALOG # 185203, LOT # UNKNOWN. BIOMET KNEE STEM CATALOG # 148146, LOT # 854590. BIOMET OFFSET ADAPTER CATALOG # 185210, LOT # 219010. BIOMET TIBIAL SM CRUCIATE WING CATALOG # 185650, LOT # 856820. 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: 0001825034-2019-02815. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS EXPERIENCING PAIN POST OPERATIVE. THE PATIENT REPORTED ONGOING MODERATE TO SEVERE KNEE PAIN AT EACH ANNUAL VISIT WITH A DECREASE IN KNEE FLEXION. 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
    542934 VANGUARD SSK PS TIBIAL BEARING PROSTHESIS KNEE HRY ZIMMER BIOMET, INC. N/A 760170

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention