BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER SCREW

    MDR report key: 6657535 · Received June 21, 2017

    Report

    Report Number
    0001822565-2017-04347
    Event Type
    Injury
    Date Received
    June 21, 2017
    Report Date
    June 21, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    HWC
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. A DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. A COMPLAINT HISTORY REVIEW WAS UNABLE TO BE PERFORMED AS THE PART AND LOT NUMBERS ARE UNKNOWN. A ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. BIGGI ET AL. "LAST GENERATION INTRAMEDULLARY NAILING SYSTEM FOR LONG BONE FRACTURES" IN-DEPTH ORAL PRESENTATIONS AND ORAL COMMUNICATIONS. J ORTHOPAED TRAUMATOL (2010) 11 (SUPPL 1):S63¿S80 DOI 10.1007/S10195-010-0111-1. THE ARTICLE WAS WRITTEN BY G. DELLA ROTONDA, R RUSSO WITH EXCERPTS FOR TRAUMATOLOGY, F. BIGGI, F. DALLA VESTRA, T. PAGLIARA, AND C. SALFI AT HOSPITAL ORTHOPAEDICS AND TRAUMATOLOGY DEPARTMENT, SAN MARTINO HOSPITAL BELLUNO, ITALY. THE COMPLAINT DEVICE IS NOT EXPECTED FOR RETURN CURRENTLY, BUT A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT ONE (1) PATIENT TREATED WITH INTRAMEDULLARY LOCKING NAIL SYSTEM EXPERIENCED AN UNKNOWN MILD COMPLICATION DUE TO SCREW BREAKAGE. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION HOWEVER FURTHER INFORMATION IS NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438341 UNKNOWN ZIMMER SCREW PROSTHESIS, KNEE HWC ZIMMER, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention