BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK DVR PLATE

    MDR report key: 6966583 · Received October 20, 2017

    Report

    Report Number
    0001825034-2017-09506
    Event Type
    Injury
    Date Received
    October 20, 2017
    Date of Event
    June 1, 2017
    Report Date
    November 10, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HRS
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. DATE OF EVENT: ARTICLE WAS PUBLISHED IN (B)(6) 2017. ROOT CAUSE REMAINS UNDETERMINED. 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). REPORT SOURCE: FOREIGN; LITERATURE. THE EVENT OCCURRED IN (B)(6). CHA, S. M., SHIN, H. D., & HWANG, S. J. (2017). TEMPORARY IPSILATERAL STIFF SHOULDER AFTER OPERATIVE FIXATION OF DISTAL RADIAL FRACTURES. JOURNAL OF SHOULDER AND ELBOW SURGERY, 26(6), 923-930. 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

    THE JOURNAL ARTICLE REPORTED A SUPERFICIAL INFECTION DEVELOPED 2 WEEKS AFTER SURGERY IN ONE PATIENT. THE INFECTION WAS TREATED WITH THREE DAYS OF ANTIBIOTICS. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745518 UNK DVR PLATE PROSTHESIS, TRAUMA HRS ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention