BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN CHS COMPRESSION HIP SCREW SCREW

    MDR report key: 14830881 · Received June 27, 2022

    Report

    Report Number
    1020279-2022-03121
    Event Type
    Injury
    Date Received
    June 27, 2022
    Date of Event
    October 20, 2012
    Report Date
    August 16, 2022
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    KTT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4). KOUVIDIS, G., SAKELLARIOU, V. I., MAVROGENIS, A. F., STAVRAKAKIS, J., KAMPAS, D., GALANAKIS, J.,& KATONIS, P. (2012). DUAL LAG SCREW CEPHALOMEDULLARY NAIL VERSUS THE CLASSIC SLIDING HIP SCREW FOR THE STABILIZATION OF INTERTROCHANTERIC FRACTURES. A PROSPECTIVE RANDOMIZED STUDY. STRATEGIES IN TRAUMA AND LIMB RECONSTRUCTION, 7(3), 155-162. DOI: 10.1007/S11751-012-0146-3.

    Additional Manufacturer Narrative · 0

    H10: THE DEVICES WERE NOT RETURNED FOR EVALUATION AND THE REPORTED EVENT COULD NOT BE CONFIRMED. THE CLINICAL/MEDICAL INVESTIGATION CONCLUDED THAT, THE LITERATURE ARTICLE WAS REVIEWED. HOWEVER, IT WAS REPORTED NO FURTHER INFORMATION IS AVAILABLE. CONSEQUENTLY, WITHOUT CLINICALLY RELEVANT PATIENT-SPECIFIC SUPPORTING DOCUMENTATION, A THOROUGH MEDICAL INVESTIGATION COULD NOT BE PERFORMED. THE IMAGES PROVIDED IN THE ARTICLE HAVE BEEN INTERPRETED WITHIN THE TEXT; THEREFORE, NO FURTHER ANALYSIS OF THE IMAGES IS REQUIRED. THE ROOT CAUSE AND/OR PATIENT OUTCOME BEYOND THAT WHICH WAS DOCUMENTED IN THE ARTICLE COULD NOT BE CONFIRMED NOR CONCLUDED; THEREFORE, NO FURTHER MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCTS FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. POSSIBLE CAUSES COULD INCLUDE BUT NOT LIMITED TO TRAUMATIC INJURY, SURGICAL TECHNIQUE OR SIZE OF DEVICE. THE CONTRIBUTION OF THE DEVICES TO THE REPORTED EVENT COULD NOT BE CORROBORATED. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. WITHOUT THE RETURN OF THE ACTUAL PRODUCTS INVOLVED, OUR INVESTIGATION COULD NOT PROCEED. SHOULD THE DEVICES OR ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT; HOWEVER, WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. WE CONSIDER THIS INVESTIGATION CLOSED. INTERNAL COMPLAINT REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON LITERATURE REVIEW "DUAL LAG SCREW CEPHALOMEDULLARY NAIL VERSUS THE CLASSIC SLIDING HIP SCREW FOR THE STABILIZATION OF INTERTROCHANTERIC FRACTURES. A PROSPECTIVE RANDOMIZED STUDY", FIVE (5) PATIENTS WHO UNDERWENT PRIMARY IMPLANTATION WITH A SLIDING HIP SCREW AND PLATE TO TREAT EXTRA-CAPSULAR HIP FRACTURES REQUIRED AN ADDITIONAL SURGERY DUE TO LAG SCREW CUT OUT. FROM THESE, TWO (2) PATIENTS REQUIRED A NEW SLIDING HIP SCREW AND PLATE IN A POSTOPERATIVE PERIOD BETWEEN TWO (2) AND THREE (3) MONTHS AFTER INITIAL SURGERY. THE REMAINING THREE (3) PATIENTS DID NOT REQUIRE ANY ADDITIONAL PROSTHESIS IN EXCHANGE, AS THE FRACTURES HAD BEEN ALREADY HEALED. THE OUTCOME OF THE TWO (2) PATIENTS WHO UNDERWENT REVISION SURGERY IS NOT KNOWN. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1938413 UNKN CHS COMPRESSION HIP SCREW SCREW APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT KTT SMITH & NEPHEW, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H UNKN CHS COMPRESSION HIP SCREW PLATE