BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN. SL-PLUS STEM

    MDR report key: 9772742 · Received March 1, 2020

    Report

    Report Number
    9613369-2020-00035
    Event Type
    Injury
    Date Received
    March 1, 2020
    Date of Event
    January 1, 1901
    Report Date
    May 5, 2020
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS AG
    Product Code
    JDH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE STUDY OF LI GUOQING [1] REPORTS THE USE OF DEVICES IN PATIENTS WITH COMPLICATIONS, IN WHICH AN SL-PLUS STEM WAS USED. IT WAS REPORTED THAT THE PATIENT WAS IN CLOSE OBSERVATION AND REHABILITATION EXERCISE DUE TO A FRACTURE OF A WIRE CABLE. THE PART AND THE BATCH NUMBER OF THIS DEVICE ARE NOT KNOWN. THEREFORE, THE BATCH RECORD REVIEW AND A COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED. THE IFU (LIT. NO. 12.23 ED. 05/16) STATES IMPLANT FRACTURE AS A KNOWN POSSIBLE BUT VERY RARE SIDE EFFECT RESULTING FROM A HIP ARTHROPLASTY. THE SEVERITY AND THE FAILURE MODE ARE COVERED THROUGH OUR RISK MANAGEMENT. AS NO DEVICE WAS RECEIVED FOR INVESTIGATION, A VISUAL INSPECTION COULD NOT BE PERFORMED. NO PATIENT INFORMATION NOR ANY OTHER MEDICATION DOCUMENTATION WAS PROVIDED, THEREFORE, A THOROUGH MEDICAL INVESTIGATION COULD NOT BE PERFORMED. BASED ON OUR INVESTIGATIONS THE FAILURE MODE CANNOT BE CONFIRMED AND THE ROOT CAUSE OF THE PROBLEM STAYS UNDETERMINED DUE TO INSUFFICIENT INFORMATION. TO DATE, NO FURTHER ACTIONS WILL BE TAKEN. SMITH AND NEPHEW WILL MONITOR THE DEVICES FOR FURTHER SIMILAR ISSUES. [1]: LI GUOQING; ZHEJIANG MEDICINE, 2018: HTTP://DX.DOI.ORG/10.12056/J.ISSN.1006-2785.2018.40.16.2017-2023

    Description of Event or Problem · 1

    IN A SCIENTIFIC PUBLICATION, AUTHOR: LI GUOQING ET ALL, "EFFICACY OF BIPOLAR ARTIFICIAL FEMORAL HEAD REPLACEMENT IN THE TREATMENT OF UNSTABLE INTERTROCHANTERIC FRACTURES IN ELDERLY PATIENTS" IT WAS REPORTED THAT THE PATIENT WAS IN CLOSE OBSERVATION AND REHABILITATION EXERCISE DUE TO A FRACTURE OF A WIRE CABLE. THERE WERE THREE TYPES OF STEM USED ON THIS STUDY, THE SL-PLUS STEM AND 2 COMPETITOR DEVICES. THERE IS NOT ENOUGH INFORMATION IN OTHER TO DETERMINE WHICH DEVICE WAS USED ON EACH PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236077 UNKN. SL-PLUS STEM PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL JDH SMITH & NEPHEW ORTHOPAEDICS AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other