BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY 28N 54 LINER

    MDR report key: 2093753 · Received May 12, 2011

    Report

    Report Number
    1818910-2011-08080
    Event Type
    Injury
    Date Received
    May 12, 2011
    Date of Event
    April 12, 2011
    Report Date
    April 14, 2026
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDI
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE STEM AT BOTH INTERFACES. THE MANUFACTURER OF THE CEMENT USED IN THE PRIMARY SURGERY IS UNKNOWN. ECCENTRIC POLY WEAR OF THE LINER WAS ALSO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY 28N 54 LINER TOTAL HIP PROSTHESIS JDI DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention