BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECUR-FIT MAX 127 HIP STEM #8

    MDR report key: 3093524 · Received May 6, 2013

    Report

    Report Number
    0002249697-2013-01554
    Event Type
    Injury
    Date Received
    May 6, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 11, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LZO
    PMA / PMN Number
    K051738
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS RETAINED BY THE PATIENT AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED, BUT NOT MADE AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS REPORTED FOR THE REPORTED MANUFACTURING LOT. PATIENT DETAILS WERE REVIEWED AND NO INDICATION WAS FOUND THAT THE EVENT WAS RELATED TO DEVICE DESIGN, MATERIALS, OR MANUFACTURING. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE OF THE REPORTED EVENT DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    PATIENT NOTICED HER LEG WAS SUDDENLY SHORTER, FOLLOWED UP WITH SURGEON - DIAGNOSIS: SUBSIDED STEM, POSSIBLE FRACTURE.

    Description of Event or Problem · 1

    PATIENT NOTICED HER LEG WAS SUDDENLY SHORTER, FOLLOWED UP WITH SURGEON - DIAGNOSIS: SUBSIDED STEM, POSSIBLE FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197232 SECUR-FIT MAX 127 HIP STEM #8 IMPLANT LZO STRYKER ORTHOPAEDICS-MAHWAH MMAHDN

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention