BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    132 SIZE 5 SECUR-FIT ADVANCED STEM

    MDR report key: 3881988 · Received June 18, 2014

    Report

    Report Number
    0002249697-2014-02358
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 29, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K122853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS REPORTED FOR THE REPORTED MANUFACTURING LOT VISUAL INSPECTION OF THE RETURNED STEM NOTED THE STEM TO BE UNREMARKABLE. DEVICE MARKING CONFIRMED THE RETURNED DEVICE. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION WAS PERFORMED ON THREE DIMENSIONS. THE TREE DIMENSIONS THE STEM OFFSET, DISTAL STEM LENGTH AND THE PROXIMAL STEM LENGTH WERE MEASURE AND FOUND TO BE WITHIN SPECIFICATION. PROFILES WERE NOT RE-INSPECTED AS THE HA COATING WAS COMPROMISED AS THE DEVICE WAS IMPLANTED AND THEN REMOVED FROM THE PATIENT THEREFORE COMPROMISING DIMENSIONS. FUNCTIONAL INSPECTION: NOT PERFORMED AS THE DIMENSIONAL INSPECTION CONFIRMED THE SIZING OF THE DEVICE. 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 INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PRIMARY SURGERY USING SECUREFIT ADV STEM, SURGEON BROACHED TO A SIZE 5 WITH TIGHT FILL, WENT TRIED TO PUT STEM IN UPON INSERTION IT FELL BELOW THE CALCAR RESECTION. THE USE OF THIS STEM WAS ABANDON, SURGEON TRIED ANOTHER SIZE 5 WITH SAME RESULTS. THEN SURGEON BROACHED TO SIZE 6 SECUREFIT ADVANCE, BUT BROACH WAS TOO BIG FOR THE PATIENT SO SECUREFIT ADV STEM WAS ABANDONED AND SURGEON WENT TO THE J-SECUREFIT PLUS SIZE 7 AND IMPLANTED THAT IN THE PATIENT.

    Description of Event or Problem · 1

    AS PER EMAIL FROM THE REP RECEIVED 06/06/14: WE TOOK THE FIRST 5 STEM OUT THAT WAS WASTED..IT SUNK WELL BELOW THE RESECTION ..HE THEN WAS CONCERNED IT STEM WAS MISLABELED. SO TRIED ANOTHER 5 STEM AND IT DID THE SAME THING. HE TRIED TO BROACH UP TO A 6 SECURFIT ADVANCE..BROACH WAS TOO BIG FOR PATIENT. WE ABANDONED SECURFIT ADV STEM AND WENT TO THE J-SECURFIT PLUS AND FIT A 7 IN PATIENT. (B)(6) HAS A V40 VERSION OF SECURFIT PLUS..CALLED J SUPER SECURFIT PLUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359301 132 SIZE 5 SECUR-FIT ADVANCED STEM IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH MME8YE

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other