BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3103220 · Received May 9, 2013

    Report

    Report Number
    0002249697-2013-01599
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    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 CITATION STEM (MONOLITHIC). IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THERE WERE NO REPORTED DISCREPANCIES AND THERE WERE NO OTHER EVENTS FOR THE REFERENCED LOT. THE REPORTED DEVICE WAS NOT RETURNED FOR EVALUATION. A MEDICAL REVIEW WAS NOT PERFORMED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION, OPERATIVE REPORTS, PROGRESS NOTES, AND X-RAYS ARE NEEDED TO FULLY INVESTIGATE THE EVENT AND TO ESTABLISH WHAT THE INDICATION FOR SURGERY WAS. THE REPORTED EVENT REGARDING REVISION OF A CITATION TMZF HA SHORT SIZE#4R WAS NOT CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A RIGHT HIP REVISION DONE DUE TO A LOOSE STEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A RIGHT HIP REVISION DONE DUE TO A LOOSE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203574 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other| R