BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECUR-FIT MAX 132 HIP STEM #9

    MDR report key: 2934631 · Received January 30, 2013

    Report

    Report Number
    0002249697-2013-00453
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 9, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE WERE NO SIMILAR EVENTS FOR THE REPORTED LOT. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE VERY LIMITED INFORMATION WAS PROVIDED; HOWEVER, IT IS BELIEVED THE PERIPROSTHETIC FRACTURE OCCURRED DUE TO TRAUMA, AS STATED IN THE EVENT DESCRIPTION, AND IS NOT DEVICE RELATED. ADDITIONAL INFORMATION, INCLUDING THE RETURNED DEVICE AND MEDICAL RECORDS ARE NEEDED TO FULLY INVESTIGATE THE EVENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT FELL AND FRACTURED FEMUR AROUND IMPLANT. A RESTORATION MODULAR WAS USED WITH CABLES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT FELL AND FRACTURED FEMUR AROUND IMPLANT. A RESTORATION MODULAR WAS USED WITH CABLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41307 SECUR-FIT MAX 132 HIP STEM #9 IMPLANT LZO STRYKER ORTHOPAEDICS-MAHWAH MLA5M6

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention