BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VISION CUP

    MDR report key: 7069049 · Received November 29, 2017

    Report

    Report Number
    0001825034-2017-10644
    Event Type
    Injury
    Date Received
    November 29, 2017
    Date of Event
    March 23, 2017
    Report Date
    November 29, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MEH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE, FOREIGN ¿ EVENTS OCCURRED IN (B)(6). REPORT SOURCE, LITERATURE - HUGHES, R. E., BATRA, A., & HALLSTROM, B. R. (2017). ARTHROPLASTY REGISTRIES AROUND THE WORLD: VALUABLE SOURCES OF HIP IMPLANT REVISION RISK DATA. CURRENT REVIEWS IN MUSCULOSKELETAL MEDICINE, 10(2), 240-252. DOI:10.1007/S12178-017-9408-5 REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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 365 PATIENTS WERE REVISED DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845717 UNKNOWN VISION CUP PROSTHESIS, HIP MEH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R