BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDROSET INJECTABLE CEMENT KIT 3CC

    MDR report key: 3113913 · Received May 15, 2013

    Report

    Report Number
    0008010177-2013-00018
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 25, 2013
    Manufacturer
    STRYKER INSTRUMENTS-FREIBURG
    Product Code
    GXP
    PMA / PMN Number
    K060763
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    HYDROSET WAS IMPLANTED IN THE PATIENT AND IT WAS NOTICED AFTER THE SURGERY THAT THE LOT CODE HAD EXPIRED TWO DAYS PRIOR TO THE SURGERY. THIS IS AN OFF LABEL USE OF THE PRODUCT AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS COMPLAINT. THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT IS STILL IMPLANTED IN THE PATIENT. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WILL NOT BE RETURNED FOR INVESTIGATION AS IT IS STILL IMPLANTED IN THE PATIENT. INVESTIGATION IN PROGRESS BUT NOT YET COMPLETE. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: AFTER REVIEWING THE INITIAL INVESTIGATION, IT WAS DECIDED TO INCLUDE AND TO ATTACH THE ORIGINAL LABEL IN THE INVESTIGATION DETAILS/DOCUMENTATION. AFTER RECEIVING THE LABEL, IT WAS FOUND THAT THE REPORTED OBSERVATION CANNOT BE CONFIRMED. THE INVESTIGATION WAS THEREFORE REOPENED IN ORDER TO REVISE THE INITIAL EVALUATION. THE LABEL SHOWS AN EXPIRY DATE: (B)(6) 2013 AND THE DECODED BARCODE (+E18239700302, +$$3130131IC009872F) CONFIRMED THAT (DECODED: 130131 = (B)(6) 2013). THE FAILURE MODE CANNOT BE CONFIRMED AS THE PRODUCT USED IN THE SURGERY WAS NOT EXPIRED (EXPIRY DATE: (B)(6) 2013) AT THE TIME OF THE SURGERY ((B)(6) 2013). BASED ON FURTHER INFORMATION PROVIDED BY STRYKER ORTHOPAEDICS MAHWAH IT WAS DETERMINED THAT THE FAILURE WAS THE RESULT OF A SYSTEMATIC PROBLEM WITH THE ORACLE PROGRAM USED BY THE CUSTOMER SERVICE DEPARTMENT, WHICH SHOWS AN EARLIER EXPIRY DATE THAN IT REALLY IS. THIS SYSTEMATIC PROBLEM WAS ADDRESSED BY THE INITIATOR OF THE COMPLAINT TO THE STRYKER CORPORATE INVENTORY TEAM. THE IMPLANT WAS BILLED AFTER ADDRESSING THE EVENT AND THE ITEM HAD BEEN UPDATED IN ORACLE. BASED ON THE INVESTIGATION PERFORMED THERE ARE NO INDICATIONS FOR ANY SYSTEMATIC DESIGN, MATERIAL OR MANUFACTURING RELATED ISSUE. THEREFORE NO CORRECTIVE AND/OR PREVENTIVE ACTIONS ARE DEEMED NECESSARY AT THIS TIME. PRODUCT IS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT EXPIRED HYDROSET WAS IMPLANTED IN THE PATIENT. IT WAS NOTICED AFTER THE SURGERY THAT THE LOT CODE HAD EXPIRED TWO DAYS PRIOR TO THE SURGERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT EXPIRED HYDROSET WAS IMPLANTED IN THE PATIENT. IT WAS NOTICED AFTER THE SURGERY THAT THE LOT CODE HAD EXPIRED TWO DAYS PRIOR TO THE SURGERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT EXPIRED HYDROSET WAS IMPLANTED IN THE PATIENT. IT WAS NOTICED AFTER THE SURGERY THAT THE LOT CODE HAD EXPIRED TWO DAYS PRIOR TO THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215525 HYDROSET INJECTABLE CEMENT KIT 3CC IMPLANT GXP STRYKER INSTRUMENTS-FREIBURG IC00987

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR