BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYPE SCL 2 LATERALIZED CEMENTLESS STEM

    MDR report key: 21156449 · Received January 15, 2025

    Report

    Report Number
    3008668801-2025-00014
    Event Type
    Injury
    Date Received
    January 15, 2025
    Date of Event
    December 17, 2024
    Report Date
    February 4, 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

    REPORTED EVENT : AN EVENT REGARDING SUBSIDENCE (LEADING TO REVISION) INVOLVING AN HYPE SCL 2 LATERALIZED CEMENTLESS STEM WAS REPORTED. CONCLUSIONS : THE REPORTED DEVICE IS AN SERF PRODUCT. NO NON-COMPLIANCE OBSERVED IN THIS BATCH 20 UNITS MARKETED BY SERF IN OCTOBER 2011 A COMPLAINT WAS RECORDED ON THIS BATCH RC-24-0408 AS PART OF THE SAME CLINICAL STUDY BUT FOR A DIFFERENT EVENT WHOSE CAUSE COULD NOT BE ESTABLISHED. LACK OF TECHNICAL INVESTIGATION: NO PRODUCT RETURN - COMPLAINT RELATED TO A CLINICAL STUDY IN THE ABSENCE OF FURTHER INFORMATION, THE CAUSE CANNOT BE ESTABLISHED. CORRECTIVE ACTION/PREVENTIVE ACTION: NO ACTION IS REQUIRED BY STRYKER AT THIS TIME AS THE INVESTIGATION FOR THIS EVENT IS PERFORMED BY SERF.

    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.

    Additional Manufacturer Narrative · 0

    MANUFACTURER ENTITY D3 CORRECTED TO S.E.R.F SOCIETE DETUDES RECHERCHE FABRICATION.

    Description of Event or Problem · 0

    SERF REPORTED RECEIVING RESULTS OF A CLINICAL STUDY. SUBSIDENCE AND ROTATION OF THE FEMORAL STEM (PAIN).

    Description of Event or Problem · 0

    SERF REPORTED RECEIVING RESULTS OF A CLINICAL STUDY. SUBSIDENCE AND ROTATION OF THE FEMORAL STEM (PAIN).

    Description of Event or Problem · 0

    SERF REPORTED RECEIVING RESULTS OF A CLINICAL STUDY. SUBSIDENCE AND ROTATION OF THE FEMORAL STEM (PAIN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1274280 HYPE SCL 2 LATERALIZED CEMENTLESS STEM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LZO S.E.R.F SOCIETE DETUDES RECHERCHE FABRICATION 1107148A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R