BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 4210956 · Received October 29, 2014

    Report

    Report Number
    0002249697-2014-04051
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    October 3, 2014
    Report Date
    October 3, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN SERIES 1 OR 2 LINERS. OTHER DEVICE LISTED IN THIS REPORT IS AN UNKNOWN 26MM C TAPER FEMORAL HEAD, +0. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE SUBMITTED IN A FOLLOW UP REPORT UPON COMPLETION OF THE INVESTIGATION. PATIENT KEPT.

    Description of Event or Problem · 1

    PATIENT PRESENTED WITH HIP PAIN SO DOCTOR REPLACED HEAD AND LINER. IT WAS A RIGHT HIP. REP WAS NOT ABLE TO GET A PART NUMBER OR LOT CODE. THEY WERE DAMAGED AND COULD NOT BE READ.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692310 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention