BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SL-PLUS/SBG/IPA MIA OFFSET ADAPTER 40MM

    MDR report key: 12239460 · Received July 28, 2021

    Report

    Report Number
    9613369-2021-00327
    Event Type
    Malfunction
    Date Received
    July 28, 2021
    Date of Event
    July 14, 2021
    Report Date
    July 13, 2023
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS AG
    Product Code
    JDI
    UDI-DI
    07611996074895
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H6: IT WAS REPORTED THAT, AFTER A TOTAL HIP REPLACEMENT SURGERY, A SL-PLUS MIA OFFSET ADAPTER 40MM BROKE. THE DEVICE, USED IN TREATMENT, WAS NOT RETURNED FOR INVESTIGATION. A PRODUCT EVALUATION COULD THEREFORE NOT BE PERFORMED. A COMPLAINT HISTORY REVIEW WAS PERFORMED. AS THE PART WAS NOT RETURNED FOR INVESTIGATION, THE REPORTED FAILURE MODE COULD NOT BE CONFIRMED AND A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE CANNOT BE CONFIRMED. BASED ON THE AVAILABLE INFORMATION IT IS NOT POSSIBLE TO INVESTIGATE WHETHER THE REPORTED DEVICE MET MANUFACTURING SPECIFICATIONS UPON RELEASE FOR DISTRIBUTION. THE ROOT CAUSE COULD NOT BE DETERMINED CONCLUSIVELY AND THE NEED FOR CORRECTIVE ACTIONS IS NOT INDICATED. ACCORDING TO THE DOCUMENT "PROCESSING (CLEANING, DISINFECTION AND STERILIZATION) OF INSTRUMENTS FROM SMITH & NEPHEW ORTHOPAEDICS AG", ALL INSTRUMENTS MUST BE INSPECTED AND CONTROLLED FOR PROPER FUNCTIONING AFTER CLEANING/DISINFECTION. INSTRUMENTS SHOULD ONLY BE USED IN THEIR ORIGINAL CONDITION. DUE TO INSUFFICIENT INFORMATION IT IS NOT POSSIBLE TO SPECULATE ABOUT FACTORS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. SHOULD MORE INFORMATION BECOME AVAILABLE, THE INVESTIGATION WILL BE REOPENED. NO FURTHER ACTIONS ARE DEEMED NECESSARY AT THE TIME. SMITH+NEPHEW WILL CONTINUE TO MONITOR THIS DEVICE FOR SIMILAR ISSUES.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT, AFTER A TOTAL HIP REPLACEMENT SURGERY, A SL-PLUS MIA OFFSET ADAPTER 40MM BROKE. THE COMPLAINT DEVICE USED IN TREATMENT WAS RETURNED FOR INVESTIGATION. A VISUAL EVALUATION OF THE DEVICE WAS CONDUCTED, AND IT WAS CONCLUDED THAT ITS CLUTCH IS BROKEN. A REVIEW OF THE PRODUCTION DOCUMENTATION DID NOT DETECT ANY DEVIATION THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. THE REVIEW OF HISTORICAL COMPLAINTS FOR THE ALLEGED DEVICE REVEALED ONE ADDITIONAL SIMILAR COMPLAINT REPORTED FOR THE SAME BATCH, AND 4 ADDITIONAL SIMILAR COMPLAINTS FOR THE SAME PRODUCT NUMBER OVER THE PAST 12 MONTHS WITH SIMILAR FAILURE MODE. PREVIOUS INVESTIGATIONS REVEALED THAT UNDER SPECIFIC CIRCUMSTANCES, THE CLUTCH OF THE DEVICE MAY FRACTURE WHILE HITTING. THE ROOT CAUSE IS ATTRIBUTED TO A DESIGN ISSUE. A NEW DESIGN OF THE DEVICE HAS BEEN RELEASED IN ORDER TO REDUCE THE REOCCURRENCE OF THIS ISSUE. THIS VERSION OF THE DEVICE WILL BE MONITORED FOR SIMILAR ISSUES. THE PERFORMANCE OF THE DEVICE IS NONETHELESS WITHIN THE RISKS, WHICH ARE ANTICIPATED IN THE RISK MANAGEMENT DOCUMENTATION OF THE PRODUCT. NO FURTHER ESCALATION IS REQUIRED. A REVIEW OF THE RISK MANAGEMENT DOCUMENTATION VERIFIES THE FAILURE MODE, OCCURRENCE AND SEVERITY OF THE REPORTED ISSUE. THERE IS NO INDICATION THAT THE REPORTED DEVICE FAILED TO MEET MANUFACTURING SPECIFICATIONS UPON RELEASE FOR DISTRIBUTION. ACCORDING TO DOCUMENT "PROCESSING (CLEANING, DISINFECTION AND STERILIZATION) OF INSTRUMENTS FROM SMITH & NEPHEW ORTHOPAEDICS AG" (LIT. N°03389-EN 1363 V3 11/19), ALL DEVICES MUST BE INSPECTED AND CONTROLLED FOR PROPER FUNCTIONING AFTER CLEANING/DISINFECTION. THE NEED FOR FURTHER ACTIONS IS NOT INDICATED. NEVERTHELESS, SMITH+NEPHEW WILL CONTINUE TO MONITOR THIS DEVICE FOR SIMILAR ISSUES. THE RETURNED DEVICE WILL BE DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, AFTER A THR SURGERY, A SL-PLUS/SBG/IPA MIA OFFSET ADAPTER 40 MM BROKE. SURGERY HAD BEEN COMPLETED, WITHOUT ANY DELAY, WITH THIS DEVICE. AS THIS HAPPENED AFTER THE PROCEDURE, THE PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1134778 SL-PLUS/SBG/IPA MIA OFFSET ADAPTER 40MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI SMITH & NEPHEW ORTHOPAEDICS AG 75007308 UNK 07611996074895

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown