BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECUR-FIT HA 132 HIP STEM #10

    MDR report key: 3914077 · Received July 3, 2014

    Report

    Report Number
    0002249697-2014-02552
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K982032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    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 HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. H3 OTHER TEXT : NOT RETURNED TO THE MANUFACTURER

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PERIPROSTHETIC FRACTURE INVOLVING A SECURFIT STEM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION NOT PERFORMED AS THE REPORTED DEVICE WAS NOT RETURNED FOR EVALUATION. A MEDICAL REVIEW WAS NOT PERFORMED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW INDICATED THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    DOCTOR REMOVED THE STEM, HEAD AND LINER AND REPLACED WITH A RESTORATION MOD STEM, NEW HEAD AND LINER AND DALL MILES CABLES AND PLATES. DOCTOR FOUND THE STEM TO BE LOOSE AND A PREVIOUS FRACTURE THAT WENT ON TO A NON UNION.

    Description of Event or Problem · 1

    DOCTOR REMOVED THE STEM, HEAD AND LINER AND REPLACED WITH A RESTORATION MOD STEM, NEW HEAD AND LINER AND DALL MILES CABLES AND PLATES. DOCTOR FOUND THE STEM TO BE LOOSE AND A PREVIOUS FRACTURE THAT WENT ON TO A NON UNION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391684 SECUR-FIT HA 132 HIP STEM #10 IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 79595302

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention