BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 10857340 · Received November 17, 2020

    Report

    Report Number
    9613369-2020-00238
    Event Type
    Malfunction
    Date Received
    November 17, 2020
    Date of Event
    October 23, 2020
    Report Date
    December 7, 2020
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS AG
    Product Code
    JDI
    UDI-DI
    07611996074895
    PMA / PMN Number
    K123598
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT SOME RUST HAS STARTING TO FORM ON THE SL-PLUS/SBG/IPA MIA OFFSET ADAPTER 40MM (B)(4). THIS IS NOT A PROCEDURE-RELATED COMPLAINT AND THEREFORE, NO INJURIES OR SURGICAL DELAYS WERE REPORTED. THE DEVICE OF (B)(4), INTENDED FOR USE IN TREATMENT, WAS RETURNED FOR INVESTIGATION. UPON VISUAL INSPECTION, THE REPORTED CORROSION FAILURE MODE COULD BE CONFIRMED. THE DEVICE SHOWS SIGNS OF SUPERFICIAL CORROSION. THE CORROSION IS MOSTLY LOCATED IN CIRCULAR ACCUMULATION OR ON EDGES AND JUNCTIONS OF THE DEVICE. FURTHERMORE, SOME SIGNS OF WEAR SUCH AS DENTS AND SCRATCHES COULD BE OBSERVED. A REVIEW OF THE PRODUCTION DOCUMENTATION, INCLUDING THE MATERIAL CERTIFICATES, DID NOT REVEAL ANY DEVIATION FROM THE STANDARD OPERATING PROCEDURE. FURTHERMORE, NO ADDITIONAL COMPLAINT WITH BATCH G51306 WAS REPORTED. IT IS UNCLEAR IF INSUFFICIENT CLEANING FROM ORGANIC RESIDUES CONTRIBUTED TO THE CORROSION OF THE INSTRUMENT. THE ACCUMULATION OF THE CORROSION MIGHT BE RELATED TO THE USED STERILIZATION/ CLEANING PROCEDURE. SMITH & NEPHEW PROVIDES DETAILED INFORMATION ON CLEANING AND STERILIZATION OF INSTRUMENTS IN LEAFLET LIT. NO. 03389, ED 11/19. BASED ON THE EXECUTED INVESTIGATION STEPS, THE ROOT CAUSE OF THIS ISSUE STAYS UNDETERMINED. THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SMITH & NEPHEW WILL CONTINUE TO MONITOR THIS DEVICE FOR SIMILAR ISSUES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SOME RUST HAS STARTING TO FORM IN THE SL-PLUS/SBG/IPA MIA OFFSET ADAPTER 40MM. NO PROCEDURE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1321821 SL-PLUS/SBG/IPA MIA OFFSET ADAPTER 40MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI SMITH & NEPHEW ORTHOPAEDICS AG 75007308 651308 07611996074895

    Patients

    Seq Age Sex Outcome Treatment
    1