BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN. SL-PLUS STEM

    MDR report key: 9774165 · Received March 2, 2020

    Report

    Report Number
    9613369-2020-00048
    Event Type
    Injury
    Date Received
    March 2, 2020
    Date of Event
    January 1, 1901
    Report Date
    April 21, 2020
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS AG
    Product Code
    JDH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE STUDY OF XU QIN [1] REPORTS 25 CASES OF HETEROTOPIC OSSIFICATION. IN THIS PAPER, 64 HIPS WERE DISCUSSED INVOLVING SL-PLUS STEMS. AN UNSPECIFIED POST-OPERATIVE CONDITION WAS REPORTED FOR SL-PLUS STEMS; ONE STEM REQUIRED SURGICAL INCISION AND THE SECOND COMPLAINT WAS REPORTED FOR 24 CASES WHICH DID NOT REQUIRE SURGICAL INTERVENTION. THE PART AND THE BATCH NUMBER OF THESE DEVICES ARE NOT KNOWN. THEREFORE, THE BATCH RECORD REVIEW AND COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED FOR THE COMPLAINT DEVICES. THE DEVICE LABELING WERE REVIEWED, THE IFU FOR THE COMPLAINT DEVICES (LIT.NO. 12.23, ED. 05/16) STATED POSSIBLE SIDE EFFECTS AMONG COMMON ADVERSE EVENTS RESULTING FROM HIP ARTHROPLASTY. THE SEVERITY AND THE FAILURE MODE ARE COVERED THROUGH OUR RISK MANAGEMENT. AS THE COMPLAINT DEVICES WERE NOT RETURNED 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 FOR THE COMPLAINT DEVICES 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]: XU QIN; THE MID-TERM RESULTS OF CERAMIC TO CERAMIC COUPLED CEMENTLESS TOTAL HIP ARTHROPLASTY; ZHANJUN ORTHOPEDICS CLINICAL MASTER MARCH 20, 2013 MASTER THESIS SOUTHERN MEDICAL UNIVERSITY GUANGZHOU

    Description of Event or Problem · 1

    SCIENTIFIC PUBLICATION, AUTHOR: XU LE, "THE MID-TERM RESULTS OF CERAMIC TO CERAMIC COUPLED CEMENTLESS TOTAL HIP ARTHROPLASTY". IT WAS REPORTED THAT IN 25 HIPS THERE WAS HETEROTOPIC OSSIFICATION. THERE WAS OBSERVATION AND SURGICAL EXCISION FOR 1 CASE. IN THIS PAPER 64 HIPS WERE DISCUSSED INVOLVING SL-PLUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236439 UNKN. SL-PLUS STEM PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL JDH SMITH & NEPHEW ORTHOPAEDICS AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention