BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERAMIC

    MDR report key: 3162272 · Received June 11, 2013

    Report

    Report Number
    9613369-2013-00047
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 23, 2013
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    LPF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE RECEIVED INFORMATION (X-RAYS, SURGICAL REPORT OF REVISION) A STEEP POSITION OF HE SHELL IN SITU EXISTED PRE REVISION. A STEEP POSITION OF THE SHELL DECREASES ROM OF THE HIP JOINT POTENTIALLY RESULTING IN IMPINGEMENT BTWEEN COMPONENTS OF THE PROSTHESIS AND AN INCREASED RISK FOR SUBLUXATION OF THE BALL HEAD. HOWEVER, IT REMAINS UNCLEAR IF THE POSITION OF THE SHELL CONTRIBUTED TO THE REPORTED INCIDENT. BASED ON THE RECEIVED INFORMATION THE ROOT CAUSE AS WELL AS THE POINT IN TIME WHEN THE INSERT BREAKAGE OCCURED COULDN'T BE DEFINED CONCLUSIVELY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262292 CERAMIC CERAMIC CERAMIC INSERT STANDARD 44/36 LPF SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R