BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN 1.4MM JUGGERKNOT SOFT ANCHOR

    MDR report key: 7347043 · Received March 16, 2018

    Report

    Report Number
    0001825034-2018-01939
    Event Type
    Injury
    Date Received
    March 16, 2018
    Date of Event
    July 21, 2017
    Report Date
    March 15, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBI
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: UNKNOWN, UNKNOWN 1.4MM JUGGERKNOT SOFT ANCHOR, UNKNOWN; UNKNOWN, UNKNOWN 1.4MM JUGGERKNOT SOFT ANCHOR, UNKNOWN; UNKNOWN, UNKNOWN 1.4MM JUGGERKNOT SOFT ANCHOR, UNKNOWN; UNKNOWN, UNKNOWN 1.4MM JUGGERKNOT SOFT ANCHOR, UNKNOWN; UNKNOWN, UNKNOWN 1.4MM JUGGERKNOT SOFT ANCHOR, UNKNOWN; UNKNOWN, UNKNOWN 1.4MM JUGGERKNOT SOFT ANCHOR, UNKNOWN; UNKNOWN, UNKNOWN 1.4MM JUGGERKNOT SOFT ANCHOR, UNKNOWN. REPORT SOURCE, LITERATURE - NAKAGAWA, S. ET AL (2017). POSTOPERATIVE RECURRENCE OF INSTABILITY DUE TO NEW ANTERIOR GLENOID RIM FRACTURES AFTER ARTHROSCOPIC BANKART REPAIR. THE AMERICAN JOURNAL OF SPORTS MEDICINE, 45(12), 2840-2848. DOI: 10.1177/0363546517714476 (B)(6). 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 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 01938, 0001825034 - 2018 - 01940, 0001825034 - 2018 - 01941, 0001825034 - 2018 - 01942, 0001825034 - 2018 - 01943, 0001825034 - 2018 - 01944. PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT THE PATIENT EXPERIENCED A NEW GLENOID RIM FRACTURE AWAY FROM THE ANCHOR HOLES. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187279 UNKNOWN 1.4MM JUGGERKNOT SOFT ANCHOR FASTENER, FIXATION MBI ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Hospitalization| O