BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXETER V40 STEM 35.5MM

    MDR report key: 6709544 · Received July 12, 2017

    Report

    Report Number
    0002249697-2017-02179
    Event Type
    Malfunction
    Date Received
    July 12, 2017
    Date of Event
    June 15, 2017
    Report Date
    November 2, 2017
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K121308
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. THEY NOTED; VISUAL INSPECTION: THE INNER BLISTER, EXTERNAL BLISTER, INNER TYVEK AND EXTERNAL TYVEK WERE RECEIVED. WHEN THE CUSTOMER OPENED THE OUTER BLISTER, THE INNER TYVEK WAS STUCK ON THE OUTER TYVEK AND THE INNER TYVEK DELAMINATED. THE AREA WHERE THE DELAMINATION OCCURRED WAS INSPECTED: THE SEALING FLANGES ARE COMPLIANT, THE INNER TYVEK DOES NOT GO ON THE OUTER SEALING FLANGE. WE ASSUME THAT THE DELAMINATED TYVEK WAS CUT BY THE CUSTOMER TO COMPLETELY OPEN THE PACKAGE. 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, 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. LMO QA PRODUCT SURVEILLANCE WILL CONTINUE TO MONITOR FOR TRENDS." IF FURTHER INFORMATION BECOMES AVAILABLE THIS INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING A THA, WHEN A NURSE WAS OPENING THE PACKAGE, THE TYVEK SHEET WAS DELAMINATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING A THA, WHEN A NURSE WAS OPENING THE PACKAGE, THE TYVEK SHEET WAS DELAMINATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488823 EXETER V40 STEM 35.5MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH G7040200

    Patients

    Seq Age Sex Outcome Treatment
    1 Other