BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VANGUARD PATELLA

    MDR report key: 6788185 · Received August 11, 2017

    Report

    Report Number
    0001825034-2017-06245
    Event Type
    Injury
    Date Received
    August 11, 2017
    Date of Event
    September 30, 2016
    Report Date
    November 2, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PT IDENTIFIER: - (B)(6). CONCOMITANT MEDICAL PRODUCT: UNKNOWN VANGUARD FEMORAL COMPONENT, CAT#: UNKNOWN LOT#: UNKNOWN. UNKNOWN VANGUARD TIBIAL TRAY, CAT#: UNKNOWN LOT#: UNKNOWN. UNKNOWN VANGUARD BEARING, CAT#: UNKNOWN LOT#: UNKNOWN. INITIAL REPORTER: Z.C. LUM, A.V. LOMBARDI, J.M. HURST, M.J. MORRIS, J.B. ADAMS, K.R. BEREND ¿EARLY OUTCOMES OF TWIN-PEG MOBILE-BEARING UNICOMPARTMENTAL KNEE ARTHROPLASTY COMPARED WITH PRIMARY TOTAL KNEE ARTHROPLASTY¿ BONE JOINT J 2016;98-B(10 SUPPL B):28-33. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. A DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. A COMPLAINT HISTORY REVIEW WAS UNABLE TO BE PERFORMED AS THE PART AND LOT NUMBERS ARE UNKNOWN. A 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. PRODUCT LOCATION UNKNOWN.

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT PATELLA INFERA WAS NOTED ON POST-OPERATIVE RADIOGRAPHS OF ONE PATIENT. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569238 UNKNOWN VANGUARD PATELLA PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention