BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SL PLUS STANDARD

    MDR report key: 4192636 · Received October 22, 2014

    Report

    Report Number
    9613369-2014-00097
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 16, 2014
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS AG
    Product Code
    JDH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PERIPROSTHETIC FRACTURE --SL-PLUS STEM STANDARD / REVISION DUE TO PERIPROSTHETIC FRACTURE AFTER TRAUMA-- PATIENT HAD SL STEM IMPLANTED WITH R3 SHELL, CERAMIC SIZE 56 LINER AND CERAMIC 36MM HEAD. PATIENT FELL ON (B)(6) AND FRACTURED FEMUR, WHERE THE SL STEM BROKE THROUGH THE FEMUR DURING INCIDENT. ON (B)(6), DR (B)(6) DID A REVISION ON THE PATIENT, WHERE HE REMOVED THE SL STEM AND THE CERAMIC LINER AND BALL HEAD. HE REPLACED THE SL STEM WITH A REDAPT PF STEM AND CHANGED THE R3 CERAMIC LINER TO A POLY LINER AND AN OXINIUM HEAD. NO IMPLANTS WILL BE RETURNED AS THE PATIENT WANTED IT FOR HIMSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672155 SL PLUS STANDARD SL-PLUS STANDARD STEM 6 NON-CEMENTED JDH SMITH & NEPHEW ORTHOPAEDICS AG ED75002705 F1203179

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R