BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 10857342 · Received November 17, 2020

    Report

    Report Number
    9613369-2020-00239
    Event Type
    Malfunction
    Date Received
    November 17, 2020
    Date of Event
    October 23, 2020
    Report Date
    December 15, 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 A 75100213 POLARSTEM CASE (B)(4) IS DAMAGED. 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 TO SMITH AND NEPHEW MEMPHIS. UPON VISUAL INSPECTION, THE REPORTED FAILURE MODE COULD BE CONFIRMED. THE TRAY SHOWS SIGNS OF WEAR AND TEAR. DUE TO THE WEAR, THE BATCH NUMBER COULD NOT BE DETECTED ON THE TRAY. BASED ON THE AVAILABLE INFORMATION, THE REPORTED FAILURE IS ATTRIBUTED TO A WEAR PROBLEM AND THE ROOT CAUSE IS AN ¿END OF LIFE PROBLEM¿ 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
    1321824 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