BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYPE SCL 4 LATERALIZED CEMENTLESS STEM

    MDR report key: 21176783 · Received January 17, 2025

    Report

    Report Number
    3008668801-2025-00015
    Event Type
    Injury
    Date Received
    January 17, 2025
    Date of Event
    December 17, 2024
    Report Date
    February 10, 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

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

    Additional Manufacturer Narrative · 0

    CORRECTION PRODUCT CODE SECTION D2B. CORRECTION COMMON DEVICE NAME SECTION D2A. ADDITION OF THE LOT NUMBER SECTION D4. INVESTIGATION CONCLUSION: AN EVENT REGARDING INSTABILITY (LEADING TO REVISION) INVOLVING AN HYPE SCL 4 LATERALIZED CEMENTLESS STEM WAS REPORTED. THE REPORTED DEVICE IS AN SERF PRODUCT. DOCUMENTARY INVESTIGATION: NO NON-COMPLIANCE OBSERVED IN THIS BATCH (B)(4) UNITS MARKETED BY SERF IN APRIL 2012. TWO COMPLAINTS WERE RECORDED FOR THIS BATCH: RC-19-0261 FOR BREAKAGE OF THE STEM NECK, THE EXPLANT OF WHICH WAS EXAMINED: THE PRODUCT IS NOT IN QUESTION; THE MOST LIKELY CAUSE IS FATIGUE FAILURE LINKED TO ABNORMAL STRESSES ON THE NECK, CAUSED BY THE PATIENT'S EXCESS WEIGHT, RC-24-0418 FOR SUSPECTED INFECTION, THE CAUSE OF WHICH 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.

    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

    SERF REPORTED RECEIVING RESULTS OF A CLINICAL STUDY. STEM BREAK (REVISION).

    Description of Event or Problem · 0

    SERF REPORTED RECEIVING RESULTS OF A CLINICAL STUDY. STEM BREAK (REVISION).

    Description of Event or Problem · 0

    SERF REPORTED RECEIVING RESULTS OF A CLINICAL STUDY. STEM BREAK (REVISION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1018388 HYPE SCL 4 LATERALIZED CEMENTLESS STEM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, UNCEMENTED LZO S.E.R.F SOCIETE DETUDES RECHERCHE FABRICATION 1202160A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R