BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3672378 · Received March 11, 2014

    Report

    Report Number
    0002249697-2014-00721
    Event Type
    Malfunction
    Date Received
    March 11, 2014
    Date of Event
    February 13, 2014
    Report Date
    February 13, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS AN UNKNOWN REAMING ATTACHMENT.WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING AN UNKNOWN REAMER THAT IS TOO SMALL FOR THE STEM AND IS WOBBLING WAS REPORTED. THE EVENT WAS NOT CONFIRMED. CONCLUSIONS: THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED BECAUSE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND INSUFFICIENT INFORMATION WAS PROVIDED. CONSULTATION WITH THE SALES REPRESENTATIVE REVEALED THAT THE USER WAS USING THE WRONG ATTACHMENT. IT IS LIKELY THERE ARE NO ISSUES WITH THE REAMER BUT DEVICE EVALUATION WOULD BE NECESSARY TO COMPLETELY RULE OUT ANY ISSUES WITH THE REAMER.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THE SECURE FIT HIP SYSTEM IS WOBBLING. UPDATE -CUSTOMER STATES THE REAMER ATTACHMENT FROM STRYKER ORTHOPAEDICS IS TOO SMALL FOR THE HIP STEM. SHE SAID THE REAMER ATTACHMENT WAS WOBBLING. THERE WAS NO UNINTENDED CUTTING.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THE SECURE FIT HIP SYSTEM IS WOBBLING. UPDATE: CUSTOMER STATES THE REAMER ATTACHMENT FROM STRYKER ORTHOPAEDICS IS TOO SMALL FOR THE HIP STEM. SHE SAID THE REAMER ATTACHMENT WAS WOBBLING. THERE WAS NO UNINTENDED CUTTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145314 UNKNOWN_RECONSTRUCTIVE_PRODUCT INSTRUMENT JWH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other