BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORDERA HIP SYSTEM

    MDR report key: 22385172 · Received July 2, 2025

    Report

    Report Number
    3004153240-2025-00012
    Event Type
    Injury
    Date Received
    July 2, 2025
    Date of Event
    May 30, 2025
    Report Date
    July 2, 2025
    Manufacturer
    RESTOR3D, INC.
    Product Code
    LPH
    UDI-DI
    M572HDL060C22S011
    PMA / PMN Number
    K162719
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEWING BOTH LOTS, THIS WAS A 1 FOR 1 SWAP OF A SINGLE COMPONENT OF HIP LINERS WITHIN THE LOT. THE REMAINDER OF PARTS IN THE LOTS ARE NOT AFFECTED, THEREFORE NO FURTHER REMEDIAL ACTION IS REQUIRED. AFTER REVIEW OF PRODUCTION RECORDS, THE TWO LOTS AFFECTED WENT THROUGH CLEANING AT THE SAME TIME PRIOR TO PACKAGING.

    Description of Event or Problem · 0

    STANDARD ACETABULAR LINER, GROUP C, 36MM WAS INTENDED TO BE USED BUT THE BOX WAS MISLABELED AND THE SURGEON PUT IN A LIPPED, GROUP C, 36MM INSTEAD - HDL-060-C22L-000101. THE SURGEON REMOVED THE CUP AND OPENED A NEW LINER, PLACING A LARGER CUP AND STANDARD LINER CAUSING A DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176634 CORDERA HIP SYSTEM CORDERA ACETABULAR LINER, 36MM STANDARD LPH RESTOR3D, INC. HDL-060-C22S-000101 1842030 M572HDL060C22S011

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Unknown