BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD (TM) PS OPEN BOX FEMORAL RIGHT INTERLOK

    MDR report key: 8540956 · Received April 23, 2019

    Report

    Report Number
    0001825034-2019-01807
    Event Type
    Injury
    Date Received
    April 23, 2019
    Report Date
    December 12, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HRY
    PMA / PMN Number
    K171054
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. 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 ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: BIOMET ARCOM ALL POLY PAT. BUTTON CATALOG # 11-150828 LOT # 909580, BIOMET ARCOM ALL POLY PAT. BUTTON CATALOG # 11-150828 LOT # 881380, VANGUARD (TM) E-POLY (TM) PS TIBIAL BEARING CATALOG # EP-183660 LOT # 889000, VANGUARD (TM) E-POLY (TM) PS TIBIAL BEARING CATALOG # EP-183660 LOT # 383470, BIOMET (R) INTERLOK FIXED CRUCIATE TIBIAL PLATE WITH LOCKING BAR CATALOG # 141235 LOT # 905260, BIOMET (R) INTERLOK FIXED CRUCIATE TIBIAL PLATE WITH LOCKING BAR CATALOG # 141235 LOT # 744910. 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: 0001825034-2019-01811, 0001825034-2019-01815, 0001825034-2019-01816, 0001825034-2019-01817, 0001825034-2019-01822, 0001825034-2019-01825. 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. 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
    333031 VANGUARD (TM) PS OPEN BOX FEMORAL RIGHT INTERLOK KNEE PROSTHESIS HRY ZIMMER BIOMET, INC. N/A 905010

    Patients

    Seq Age Sex Outcome Treatment
    1 Other