BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXETER V40 STEM 37.5MM NO1L125

    MDR report key: 6710896 · Received July 13, 2017

    Report

    Report Number
    0002249697-2017-02186
    Event Type
    Malfunction
    Date Received
    July 13, 2017
    Date of Event
    May 29, 2017
    Report Date
    November 2, 2017
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT INVOLVES A DEVICE THAT IS NOT CLEARED FOR SALE IN THE U.S., BUT SIMILAR DEVICE IS COMMERCIALLY AVAILABLE IN THE U.S. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING AN PACKAGING ISSUE INVOLVING AN EXETER STEM WAS REPORTED. THE EVENT WAS CONFIRMED FOLLOWING REVIEW OF THE RETURNED DEVICE. DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION WAS CARRIED BY THE SUPPLIER (LISI MEDICAL ORTHOPAEDICS (LMO). THEY NOTED; VISUAL INSPECTION: ONLY THE EXTERNAL BLISTER, THE INNER TYVEK AND THE EXTERNAL TYVEK WERE RETURNED FOR EVALUATION. THE INNER BLISTER WAS NOT RETURNED. THE SEALING FLANGE OF THE EXTERNAL BLISTER IS COMPLIANT. THERE IS NO MARK ON THE TWO TYVEKS SHOWING THAT THE TWO TYVEKS WERE STUCK TOGETHER. MEDICAL RECORDS RECEIVED AND EVALUATION: A MEDICAL REVIEW WAS NOT PERFORMED BECAUSE NO MEDICAL INFORMATION WAS PROVIDED. DEVICE HISTORY REVIEW: REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: REVIEW INDICATED THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE REPORTED LOT. CONCLUSIONS: SUPPLIER EVALUATION: LISI MEDICAL ORTHOPAEDICS (LMO), CONDUCTED AN INVESTIGATION ON THE RETURNED DEVICE AND CONCLUDED: NO ACTION IS REQUIRED AT THIS TIME AS THERE WAS NO INDICATION OF A MANUFACTURING ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING A THA, WHEN A NURSE OPENED THE OUTER TYVEK SHEET, THE INNER TYVEK WAS ALSO PEELED WITH OUTER ONE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING A THA, WHEN A NURSE OPENED THE OUTER TYVEK SHEET, THE INNER TYVEK WAS ALSO PEELED WITH OUTER ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492305 EXETER V40 STEM 37.5MM NO1L125 HIP IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH G7038640

    Patients

    Seq Age Sex Outcome Treatment
    1 Other