BEUDAMED
    FDA Adverse Event Injury Summary report: N

    R3 PRIMARY LINERS XL CONST 58MM

    MDR report key: 3871960 · Received June 13, 2014

    Report

    Report Number
    1020279-2014-00368
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    June 11, 2014
    Report Date
    March 30, 2015
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE AFFECTED DEVICE WAS RETURNED AND EVALUATED. THE RETURNED R3 CONSTRAINED LINER COMPONENTS WERE EXAMINED VISUALLY. THE PURPOSE OF THIS INVESTIGATION WAS TO EVALUATE THE RETURNED DEVICE. NO DESTRUCTIVE TESTING WAS CARRIED OUT. THE INNER LINER LOCK RING WAS RECEIVED DISASSEMBLED FROM THE CONSTRUCT. THE TOP FACE OF THE CONSTRAINED LINER HAD SIGNS OF PLASTIC DEFORMATION. THE SIGNS OF PLASTIC DEFORMATION OBSERVED ON THE TOP FACE OF THE CONSTRAINED LINER WERE LIKELY DUE TO FEMORAL NECK IMPINGEMENT. THIS IMPINGEMENT, IF COUPLED WITH POTENTIAL HIGH LEVER-OUT FORCES, MAY HAVE RESULTED IN THE DISLOCATION OF THE INNER FEMORAL HEAD FROM THE CONSTRAINED LINER CONSTRUCT. THE INNER FEMORAL HEAD WAS NOT RETURNED THEREFORE, NO FURTHER INVESTIGATION WAS CONDUCTED.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350885 R3 PRIMARY LINERS XL CONST 58MM HIP IMPLANT JDH SMITH & NEPHEW, INC. 13GM21005

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R