BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXETER V40 STEM 44MM NO 2

    MDR report key: 4281968 · Received November 26, 2014

    Report

    Report Number
    0002249697-2014-04390
    Event Type
    Malfunction
    Date Received
    November 26, 2014
    Date of Event
    October 29, 2014
    Report Date
    October 30, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K011623
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING FOREIGN MATTER INVOLVING AN EXERTER STEM WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: A VISUAL INSPECTION CONFIRMED A HAIR WAS PRESENT FROM THE INSIDE OF THE INNER BLISTER TO THE OUTSIDE OF THE EXTERNAL BLISTER, THROUGH THE SEALING FLANGES. STRYKER (B)(4) PERFORMED AN INTEGRITY TEST (DYE PENETRATION) AND IT WAS VERIFIED THAT THE SEAL INTEGRITY WAS INTACT. DEVICE HISTORY REVIEW: DEVICE HISTORY REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: A REVIEW OF THE COMPLAINT HISTORY DATABASE SHOWS THAT THERE HAVE BEEN NO SIMILAR REPORTED EVENTS FOR THE SUBJECT LOT CODE. CONCLUSIONS: THE INVESTIGATION CONCLUDED THAT A HAIR WAS PRESENT WITHIN THE SEALS OF THE RETURNED PACKAGING. LMO WAS RAISED BY THE SUPPLIER TO INVESTIGATE FURTHER.

    Description of Event or Problem · 1

    THE SALES REP. HAS REPORTED ON BEHALF OF THE CUSTOMER, THAT DURING SURGERY IT WAS NOTICED THAT A LONG, DARK HAIR WAS SEALED HALF INSIDE THE INNER PACKAGING OF AN EXETER STEM AND HALF OUTSIDE WHICH HAS ALLEGEDLY COMPROMISED THE STERILITY OF THE IMPLANT. THE SALES REP HAS REPORTED THAT ANOTHER STEM WAS IMMEDIATELY AVAILABLE TO COMPLETE THE SURGERY AS THEY KEEP MULTIPLE LEVELS OF STOCK ON THEIR SHELVES.

    Description of Event or Problem · 1

    THE SALES REP. HAS REPORTED ON BEHALF OF THE CUSTOMER, THAT DURING SURGERY IT WAS NOTICED THAT A LONG, DARK HAIR WAS SEALED HALF INSIDE THE INNER PACKAGING OF AN EXETER STEM AND HALF OUTSIDE WHICH HAS ALLEGEDLY COMPROMISED THE STERILITY OF THE IMPLANT. THE SALES REP HAS REPORTED THAT ANOTHER STEM WAS IMMEDIATELY AVAILABLE TO COMPLETE THE SURGERY AS THEY KEEP MULTIPLE LEVELS OF STOCK ON THEIR SHELVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768353 EXETER V40 STEM 44MM NO 2 IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH G4416006

    Patients

    Seq Age Sex Outcome Treatment
    1 Other