BEUDAMED
    FDA Adverse Event Injury Summary report: N

    O-F II ACET SHELL 48MM

    MDR report key: 7436677 · Received April 17, 2018

    Report

    Report Number
    1020279-2018-00767
    Event Type
    Injury
    Date Received
    April 17, 2018
    Date of Event
    April 13, 2015
    Report Date
    April 17, 2018
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASSOCIATED COMPLAINT DEVICES WERE NOT RETURNED. THE CLINICAL/MEDICAL TEAM CONCLUDED, BASED ON THE AVAILABLE INFORMATION, THE ROOT CAUSE FOR THE "LOOSENING" OR THE "INFECTION" CANNOT BE CONCLUDED. SHOULD ANY RELEVANT CLINICAL/MEDICAL INFORMATION BECOME AVAILABLE THIS COMPLAINT CAN BE RE-ASSESSED. A REVIEW OF COMPLAINT HISTORY FOR THE LISTED PARTS REVEALED NO PRIOR COMPLAINTS FOR THE LISTED BATCHES. WITHOUT THE ACTUAL PRODUCT INVOLVED, OUR INVESTIGATION CANNOT PROCEED. IF THE DEVICE OR NEW INFORMATION IS RECEIVED IN THE FUTURE, THIS COMPLAINT CAN BE RE-OPENED. WE CONSIDER THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280349 O-F II ACET SHELL 48MM PRSTHSIS, HIP SEMCONSTRAINED, MTAL/POLYER,CENTD JDI SMITH & NEPHEW, INC. OR427548 4A69863

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R