BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3103414 · Received May 9, 2013

    Report

    Report Number
    0002249697-2013-01609
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 22, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER IS UNKNOWN AT THIS TIME. THE DEVICE WAS REPORTED AS AN UNKNOWN 40MM TRIDENT LINER. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. PATIENT KEPT.

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6). AN EVENT REGARDING DISLOCATION REGARDING AN UNKNOWN TRIDENT LINER WAS REPORTED. THE EVENT WAS NOT CONFIRMED. THE EXACT ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS A FREQUENT DISLOCATOR AND THE SURGEON ELECTED TO CHANGE ACETABULAR LINER FOR A CONSTRAINED LINER FOR A GREATER STABILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS A FREQUENT DISLOCATOR AND THE SURGEON ELECTED TO CHANGE ACETABULAR LINER FOR A CONSTRAINED LINER FOR A GREATER STABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203757 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention