BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3082095 · Received April 29, 2013

    Report

    Report Number
    0002249697-2013-01467
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    November 16, 2007
    Report Date
    July 11, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A FEMORAL PERIPROSTHETIC FRACTURE INVOLVING AN UNKNOWN SHELL, ACETABULAR TRIDENT PAL SZ 50 WAS REPORTED. IT COULD NOT BE DETERMINED WHETHER OR NOT THE PATIENT WAS IMPLANTED WITH A STRYKER STEM. THE TRIDENT SHELL DOES NOT INTERFERE WITH THE FEMORAL STEM/BONE INTERFACE.

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER IS UNKNOWN AT THIS TIME. THE DEVICE WAS REPORTED AS AN UNKNOWN SHELL, ACETABULAR TRIDENT PAL SZ 50. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A FEMORAL FRACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A FEMORAL FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185836 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other| R