BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD DCM POSTERIOR STABILIZED TIBIAL BEARING 10MM X 71/75MM

    MDR report key: 7944395 · Received October 8, 2018

    Report

    Report Number
    0001825034-2018-09513
    Event Type
    Injury
    Date Received
    October 8, 2018
    Report Date
    December 18, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK113550
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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 FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: VANGUARD POSTERIOR STABILIZED INTERLOK FEMORAL COMPONENT RIGHT 72.5, CATALOG #: 183113, LOT #: 038480, BIOMET SERIES A STANDARD PATELLA 37MM, CATALOG #: 184768, LOT #: 008140, BIOMET CC CRUCIATE TRAY 75MM, CATALOG #: 141234, LOT #: J2905419. IT IS NOT KNOWN AT THIS TIME WHETHER THE EXPLANTED DEVICE WILL 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.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY REVISION OF THE POLYETHYLENE BEARING AND REMOVAL OF SCAR TISSUE DUE TO SYMPTOMS OF PAIN AND SWELLING EIGHTEEN (18) MONTHS POST-OPERATIVELY. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785650 VANGUARD DCM POSTERIOR STABILIZED TIBIAL BEARING 10MM X 71/75MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 394050

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R