BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VAN PS OPEN INTL FEM-RT 65

    MDR report key: 8293903 · Received January 31, 2019

    Report

    Report Number
    0001825034-2019-00399
    Event Type
    Injury
    Date Received
    January 31, 2019
    Date of Event
    February 3, 2017
    Report Date
    October 23, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K171054
    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

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD 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. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). IMPLANT DATE - (B)(6), 2015. 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.

    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 PRODUCTS: CATALOG #: 141224, BIOMET CC I-BEAM TRAY, LOT # J3164705. CATALOG #: EP-183644, E1 VNGD PS TIB BRG, LOT # 919930. CATALOG #: 184764, SERIES A PAT STD 31 3 PEG, LOT # 834870. CATALOG #: 42-422561, SIG TKA GDE/MDL SET 04-05, LOT # 127407. CATALOG #: 417200, OPTIVAC KIT 80GRAM DOUBLE MIX, LOT # 0000963917. CATALOG #: 402438, COBALT MV BONE CEMENT 40GM B, LOT # 834870. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT; PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-00400, 0001825034-2019-00401, 0001825034-2019-00402.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT TOTAL KNEE ARTHROSCOPY APPROXIMATELY 4 YEARS AGO AND SUBSEQUENTLY WAS EXPERIENCING PAIN, SWELLING HOT TO THE TOUCH, AND MOBILITY ISSUES. THE SURGEON WITHDREW FLUID SEVERAL TIMES AND THE PATIENT EVENTUALLY UNDERWENT A PROCEDURE ABOUT 2 YEARS LATER WHERE GELATINOUS MATERIAL WAS REMOVED. NO DEVICES WERE REMOVED AT THE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87706 VAN PS OPEN INTL FEM-RT 65 PROSTHESIS KNEE JWH ZIMMER BIOMET, INC. N/A 297930 

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other