BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EXTERNAL FIXATOR PIN

    MDR report key: 10049646 · Received May 12, 2020

    Report

    Report Number
    1020279-2020-01634
    Event Type
    Injury
    Date Received
    May 12, 2020
    Report Date
    September 4, 2020
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    RESULTS OF INVESTIGATION: IT WAS REPORTED FROM A LITERATURE REVIEW THAT THE PATIENT HAD 15 DEGREES RECURVATUM AFTER SURGERY THAT WAS GRADUALLY CORRECTED BY ADDING A HINGE SYSTEM TO THE FIXATOR. THE ASSOCIATED DEVICE, USED IN TREATMENT, WAS NOT RETURNED FOR EVALUATION. THUS THE PRODUCT ANALYSIS COULD NOT BE PERFORMED. AS DEVICE INFORMATION WAS NOT MADE AVAILABLE, DEVICE HISTORY RECORD AND COMPLAINT HISTORY REVIEW CANNOT BE COMPLETED. THERE IS NO INFORMATION THAT WOULD SUGGEST THE DEVICE FAILED TO MEET SPECIFICATIONS. A RELATIONSHIP, IF ANY, BETWEEN THE DEVICE AND THE REPORTED INCIDENT COULD NOT BE CORROBORATED. NO MEDICAL DOCUMENTS WERE RECEIVED FOR INVESTIGATION. THEREFORE NO MEDICAL ASSESSMENT CAN BE PERFORMED AT THIS TIME. THE PAPER WAS PUBLISHED IN 2001. THE POTENTIAL CAUSES COULD INCLUDE BUT ARE NOT LIMITED TO TRAUMA INJURY OR PATIENT MEDICAL CONDITIONS. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT; HOWEVER WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED.

    Description of Event or Problem · 1

    "ARTHRODESIS WITH THE ILIZAROV DEVICE AFTER FAILED KNEE ARTHROPLASTY". AUTHOR: RAMI DAVID, MD ET AL., ORTHO BLUE JOURNAL, 2001. ACCORDING TO THE STUDY, THIRTEEN PATIENTS WITH FAILED TOTAL KNEE ARTHROPLASTY (TKA) DUE TO INFECTION (12 PATIENTS) OR ASEPTIC LOOSENING (1 PATIENT) UNDERWENT ARTHRODESIS USING AN SMITH AND NEPHEW ILIZAROV EXTERNAL FIXATOR. IT WAS DOCUMENTED ON THE PAPER THAT ONE PATIENT HAD 15 DEGREES RECURVATUM AFTER SURGERY THAT WAS GRADUALLY CORRECTED BY ADDING A HINGE SYSTEM TO THE FIXATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510505 UNKNOWN EXTERNAL FIXATOR PIN PIN, FIXATION, THREADED JDW SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R