BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYPE SCL 3 LATERALIZED CEMENTLESS STEM

    MDR report key: 21980216 · Received May 7, 2025

    Report

    Report Number
    3008668801-2025-00107
    Event Type
    Injury
    Date Received
    May 7, 2025
    Date of Event
    September 23, 2015
    Report Date
    April 3, 2026
    Manufacturer
    S.E.R.F SOCIETE DETUDES RECHERCHE FABRICATION
    Product Code
    LZO
    PMA / PMN Number
    K223745
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    PATIENT OCCURRED A SEPSIS. THE SURGEON RE-OPERATED THE PATIENT TO WASH THE IMPLANTS WITHOUT REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227554 HYPE SCL 3 LATERALIZED CEMENTLESS STEM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS LZO S.E.R.F SOCIETE DETUDES RECHERCHE FABRICATION 1411263A

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Female Hospitalization| O