BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CABLE READY GTR PLATE

    MDR report key: 7228987 · Received January 30, 2018

    Report

    Report Number
    0001822565-2018-00600
    Event Type
    Injury
    Date Received
    January 30, 2018
    Report Date
    January 30, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HRS
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). REPORT SOURCE, LITERATURE B. GAVANIER, ET AL.,(2017). OSTEOSYNTHESIS OF PERIPROSTHETIC TYPE A AND B FEMORAL FRACTURES USING AN UNLOCKED PLATE WITH INTEGRATED CERCLAGE CABLE AND TROCHANTERIC HOOK: A MULTICENTER RETROSPECTIVE STUDY OF 45 PATIENTS WITH MEAN FOLLOW-UP OF 20 MONTHS. INJURY, 48(12), 2827-2832. DOI:10.1016/J.INJURY.2017.10.023. 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. COMPLAINT HISTORY REVIEW WAS UNABLE TO BE PERFORMED, AS THE PART NUMBER AND LOT NUMBER ARE 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. (B)(4). NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT FIVE (5) PLATES HAD EXCEEDED ANTERIORLY ON LATERAL RADIOGRAPHS, FOLLOWING FEMORAL PERI-PROSTHETIC FRACTURE PLATING PROCEDURES. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72013 UNKNOWN CABLE READY GTR PLATE PROTHESIS, TRAUMA, FIXATION HRS ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other