BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIP IMPLANT

    MDR report key: 8864300 · Received August 6, 2019

    Report

    Report Number
    1020279-2019-02914
    Event Type
    Injury
    Date Received
    August 6, 2019
    Date of Event
    May 21, 2016
    Report Date
    September 25, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE ASSOCIATED COMPLAINT DEVICES WERE NOT RETURNED. A CLINICAL EVALUATION WAS CONDUCTED AND THE CLINICAL INFORMATION PROVIDED, OF THE ¿OSTEOLYTIC/METALLOSIS AND SYNOVIAL REACTION¿ MAY BE CONSISTENT WITH A REACTION TO METAL DEBRIS. HOWEVER, THE SOURCE AND THE ROOT CAUSE CANNOT BE DETERMINED WITH THE AVAILABLE DOCUMENTATION. THE ROOT CAUSE OF THE DISLOCATIONS CANNOT BE CONCLUDED BASED ON THE INFORMATION PROVIDED. WITHOUT THE ACTUAL PRODUCT INVOLVED AND/OR DEVICE INFORMATION, OUR INVESTIGATION CANNOT PROCEED. IF THE DEVICE OR NEW INFORMATION IS RECEIVED IN THE FUTURE, THIS COMPLAINT CAN BE RE-OPENED. NO FURTHER ACTIONS ARE BEING TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT REDUCTION SURGERY DUE TO DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657229 HIP IMPLANT PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL JDH SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R