BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STEM

    MDR report key: 6794207 · Received August 15, 2017

    Report

    Report Number
    0001822565-2017-05799
    Event Type
    Injury
    Date Received
    August 15, 2017
    Date of Event
    July 13, 2017
    Report Date
    August 15, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDI
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: UNKNOWN LINER, UNKNOWN CUP, UNKNOWN HEAD. (B)(4). REPORT SOURCE, LITERATURE - MCGRORY, B. ET AL (2017). HIGH EARLY MAJOR COMPLICATION RATE AFTER REVISION FOR MECHANICALLY ASSISTED CREVICE CORROSION IN METAL-ON-POLYETHYLENE TOTAL HIP ARTHROPLASTY. THE JOURNAL OF ARTHROPLASTY, 1-7. DOI: 10.1016/J.ARTH.2017.07.004. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2017-05798, 0001822565-2017-05800, 0001822565-2017-05801.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED IN A JOURNAL ARTICLE THAT A PATIENT HAD A LOW TO POOR HARRIS HIP SCORE OF 54. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574901 UNKNOWN STEM PROSTHESIS, HIP JDI ZIMMER, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other