BEUDAMED
    FDA Adverse Event Injury Summary report: N

    132 SIZE 8 SECUR-FIT ADVANCED STEM

    MDR report key: 3781259 · Received April 30, 2014

    Report

    Report Number
    0002249697-2014-01621
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 9, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LWJ
    PMA / PMN Number
    K122853
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED IN 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. NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) IN HEIGHT. AN EVENT REGARDING STEM SUBSIDENCE INVOLVING A SECURFIT STEM WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD AND RESULTS: MEDICAL RECORDS RECEIVED AND EVALUATION: THE PROVIDED X-RAYS WERE SUBMITTED TO A CONSULTING CLINICIAN WHO DEEMED IT INSUFFICIENT FOR A MEDICAL REVIEW. STEM SUBSIDENCE CONFIRMED ON X-RAY HOWEVER OPERATIVE REPORTS AND CLINICAL HISTORY ARE NEEDED TO FURTHER INVESTIGATE. CONCLUSIONS: A MEDICAL REVIEW WAS PERFORMED AND CONFIRMED THAT THE STEM SUBSIDED HOWEVER THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED. ADDITIONAL INFORMATION, INCLUDING OPERATIVE REPORTS, PROGRESS NOTES, CLINICAL HISTORY AND RETURN OF THE DEVICE ARE NEEDED TO FULLY INVESTIGATE THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DOCTOR OBSERVED FEMORAL STEM SUBSIDENCE OF 6MM ON THE 6 WEEK X-RAYS FOR A PATIENT PARTICIPATING IN THE (B)(4) CLINICAL STUDY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DOCTOR OBSERVED FEMORAL STEM SUBSIDENCE OF 6MM ON THE 6 WEEK X-RAYS FOR A PATIENT PARTICIPATING IN THE SECUR-FIT ADVANCED POST-MARKET CLINICAL STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259272 132 SIZE 8 SECUR-FIT ADVANCED STEM IMPLANT LWJ STRYKER ORTHOPAEDICS-MAHWAH MMO52K

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other