BEUDAMED
    FDA Adverse Event Injury Summary report: N

    127 SIZE 9 SECUR-FIT ADVANCED STEM

    MDR report key: 3821583 · Received May 20, 2014

    Report

    Report Number
    0002249697-2014-01868
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    April 24, 2014
    Report Date
    April 24, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K122853
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS THE DEVICE REMAINS IMPLANTED IN THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING STEM SUBSIDENCE INVOLVING A SECUR-FIT ADVANCED STEM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD AND RESULTS: DEVICE EVALUATION AND RESULTS: COULD NOT BE PERFORMED AS NO ITEMS ASSOCIATED WITH THE EVENT WERE RETURNED OR MADE AVAILABLE FOR EVALUATION. MEDICAL RECORDS RECEIVED AND EVALUATION: NO MEDICAL RECORDS OR X-RAYS WERE MADE AVAILABLE FOR EVALUATION. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATES ALL DEVICES ACCEPTED INTO FINAL STOCK MET SPECIFICATIONS. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THIS LOT. CONCLUSIONS: THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION AND NO MEDICAL INFORMATION WAS PROVIDED. IF THE DEVICES AND/OR ADDITIONAL INFORMATION ARE RECEIVED, THIS INVESTIGATION WILL BE REOPENED AND RE-EVALUATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS A STUDY SUBJECT IN (B)(4). SUBSIDENCE OF THE FEMORAL COMPONENT SEEN ON WEEK 6 X-RAYS. THE SUBJECT WAS SEEN IN CLINIC WITH NO THIGH PAIN AND NO LUCENT LINES. DOCTOR SUSPECTED THE SUBSIDENCE OCCURRED SHORTLY AFTER SURGERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS A STUDY SUBJECT IN THE SECUR-FIT ADVANCED STUDY. SUBSIDENCE OF THE FEMORAL COMPONENT SEEN ON WEEK 6 X-RAYS. THE SUBJECT WAS SEEN IN CLINIC WITH NO THIGH PAIN AND NO LUCENT LINES. DOCTOR SUSPECTED THE SUBSIDENCE OCCURRED SHORTLY AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299273 127 SIZE 9 SECUR-FIT ADVANCED STEM IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH MMPW7E

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention