BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDROSET INJECTABLE CEMENT KIT 10CC

    MDR report key: 5183122 · Received October 28, 2015

    Report

    Report Number
    0008010177-2015-00271
    Event Type
    Malfunction
    Date Received
    October 28, 2015
    Date of Event
    October 10, 2015
    Report Date
    October 10, 2015
    Manufacturer
    STRYKER ORTHOPAEDICS-LIMERICK
    Product Code
    GXP
    PMA / PMN Number
    K060763
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT COULD NOT BE CONFIRMED, BECAUSE THE COMPLAINED DEVICE HAS NOT BEEN RETURNED. THE INVESTIGATIONS CONDUCTED ARE BASED ON THE TEST OF THE RETAIN SAMPLES AND THE REVIEW OF THE BATCH MANUFACTURING RECORD (BMR). THE DEVICE IS MANUFACTURED BY STRYKER (B)(4). THE COMPLAINT INFORMATION WAS FORWARDED TO THE MANUFACTURING FACILITY. THE RETAIN SAMPLES PASSED THE TESTS. FURTHERMORE, THE BATCH RECORD WAS INVESTIGATED BY THE SUPPLIER WITH THE FOLLOWING RESULTS: ¿(¿) IT HAS BEEN CONFIRMED THAT THE PRODUCT AND ITS COMPONENTS (LIQUID AND POWDER COMPONENTS) WERE MANUFACTURED PER VALIDATED CONDITIONS. (¿)¿. THE EXACT ROOT CAUSE COULD NOT BE DETERMINED, BUT ACCORDING TO THE DESIGN RISK ANALYSIS THESE ARE POSSIBLE ROOT CAUSES: SODIUM PHOSPHATE CRYSTALLIZES TO INNER BARREL WALL CAUSING LIQUID SYRINGE PLUNGER TO STICK. NO INDICATIONS WERE FOUND FOR ANY MATERIAL OR MANUFACTURING RELATED ISSUES. THE THRESHOLD OF THE EXPECTED OCCURRENCE RATE IS NOT EXCEEDED. THEREFORE NO FURTHER ACTIONS WERE DEEMED NECESSARY AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. DISCARDED AT THE FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE CONDUCTED AT THE USER FACILITY THE HYDROSET BECAME HIGHLY VISCOUS TO USE AFTER BEING MIXED . NO PATIENT INVOLVEMENT, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE CONDUCTED AT THE USER FACILITY THE HYDROSET BECAME HIGHLY VISCOUS TO USE AFTER BEING MIXED . NO PATIENT INVOLVEMENT, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713255 HYDROSET INJECTABLE CEMENT KIT 10CC IMPLANT GXP STRYKER ORTHOPAEDICS-LIMERICK +$IC020100R

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other