BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SMF STEM

    MDR report key: 10024989 · Received May 5, 2020

    Report

    Report Number
    1020279-2020-01453
    Event Type
    Injury
    Date Received
    May 5, 2020
    Report Date
    July 24, 2020
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED A LITERATURE REVIEW THAT THE PATIENT REQUIRED A REVISION SURGERY DUE TO PERIOPERATIVE FRACTURE IN THE PROXIMAL PART OF THE FEMORAL BONE. THE AFFECTED COMPLAINT DEVICE, USED IN TREATMENT, WAS NOT RETURNED FOR EVALUATION. THEREFORE A 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. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. THE POTENTIAL ROOT CAUSES COULD INCLUDE BUT ARE NOT LIMITED TO BONE QUALITY OR SURGICAL TECHNIQUE. WITHOUT THE RETURN OF THE ACTUAL PRODUCT INVOLVED AND NO PATIENT MEDICAL RECORDS AVAILABLE, OUR INVESTIGATION OF THIS REPORT IS INCONCLUSIVE. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT; HOWEVER WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED.

    Description of Event or Problem · 1

    "RADIOGRAPHIC ANALYSIS OF STABILITY AFTER IMPLANTATION OF THREE DIFFERENT CEMENTLESS SHORT FEMORAL STEMS ¿ FIVE YEAR FOLLOW-UP". AUTHOR: WIESLAW LACHOWICZ ET AL. JANUARY 2019; 161-165. IN THIS STUDY, 180 PATIENTS DIVIDED IN 3 GROUPS WERE ANALIZED, 60 PATIENTS EACH; 60 PATIENTS BEARING SMF FEMORAL STEM AND THE OTHER 2 GROUPS BEARING COMPETITOR DEVICES (CORIN AND JRI). IT WAS REPORTED THAT PERIOPERATIVE FRACTURE IN THE PROXIMAL PART OF THE FEMORAL BONE OCCURRED IN 4 CASES OF THE SMF GROUP. FRACTURES IN THE SAME SURGICAL PROCEDURE WERE REDUCED AND FIXATED WITH DALL-MILES CERCLAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490854 UNKNOWN SMF STEM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R