BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD PS OPEN BOX FEMORAL

    MDR report key: 7107908 · Received December 12, 2017

    Report

    Report Number
    0001825034-2017-11031
    Event Type
    Injury
    Date Received
    December 12, 2017
    Report Date
    November 20, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK171054
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE WAS NOT RETURNED. DHR WAS REVIEWED FOR DEVIATIONS AND / OR ANOMALIES WITH NO RELEVANT DEVIATIONS / ANOMALIES IDENTIFIED. 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 · 1

    (B)(4). MEDICAL PRODUCTS - BIOMET CC CRUCIATE TRAY #: 141232, LOT #: J2545284. BIOMET ARCOM PATELLA #: 11-150826, LOT #: 956920. VANGUARD DCM PS TIBIAL BEARING #: 183624, LOT #: 005910. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-11032, 0001825034-2017-11033 AND 0001825034-2017-11034. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT REMAINS IMPLANTED IN THE PATIENT. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING POST-OPERATIVE PAIN FOLLOWING KNEE ARTHROPLASTY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    887420 VANGUARD PS OPEN BOX FEMORAL PROSTHESIS KNEE JWH ZIMMER BIOMET, INC. N/A 835010

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention