BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA C-TAPER HEAD 36MM +0

    MDR report key: 3081073 · Received April 26, 2013

    Report

    Report Number
    0002249697-2013-01453
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 2, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LZO
    PMA / PMN Number
    K041940
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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

    THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS RECEIVED. REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT DATABASES WERE REVIEWED FROM DATE OF MANUFACTURE OF THE REPORTED LOT TO PRESENT FOR SIMILAR REPORTED EVENTS REGARDING DISLOCATIONS. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A REVISION OF THE RIGHT HIP DUE TO DISLOCATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A REVISION OF THE RIGHT HIP DUE TO DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182509 DELTA C-TAPER HEAD 36MM +0 IMPLANT LZO STRYKER ORTHOPAEDICS-MAHWAH 40704501

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| O| R