BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXETER V40 STEM 44MM NO 2

    MDR report key: 2974054 · Received February 22, 2013

    Report

    Report Number
    0002249697-2013-00745
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    January 31, 2013
    Report Date
    January 31, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER IS UNKNOWN AT THIS TIME. THE DEVICE WAS REPORTED AS AN UNKNOWN EXETER STEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING REVISION AND STEM CORROSION INVOLVING AN EXETER V40 STEM WAS REPORTED. THE REASON FOR REVISION WAS NOT CONFIRMED, HOWEVER CORROSION WAS NOTED ON THE STEM UPON EXPLANTATION. A MATERIAL AND VISUAL ANALYSIS INDICATED THE MEDIAL AND LATERAL SURFACES OF THE RETURNED EXETER STEM SHOWED EVIDENCE OF MICROMOTION SURFACE DAMAGES AND CORROSION PROCESSES. ABRASION BETWEEN THE IMPLANT SURFACE AND BONE CEMENT/BONY MATERIAL LIKELY CONTRIBUTED TO THESE DAMAGES. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON THE DEVICE FEATURES EVALUATED. DEVICE HISTORY RECORDS FOR THE SPECIFIC LOT INDICATED THAT THE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. A REVIEW OF THE COMPLAINT HISTORY DATABASE SHOWS THAT THERE HAVE BEEN NO SIMILAR REPORTED EVENTS FOR THE SUBJECT LOT CODE. THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AS A REASON FOR REVISION WAS NOT PROVIDED. CORROSION WAS NOTED UPON EXPLANTATION OF THE DEVICE, HOWEVER, THERE IS NO INDICATION THAT THE CORROSION CONTRIBUTED TO THE REASON FOR REVISION.

    Description of Event or Problem · 1

    SURGEON REPORTED THAT ON (B)(6) 2013, HE PERFORMED A REVISION SURGERY OF EXETER STEM IMPLANTED A FEW YEARS AGO. ACCORDING TO SURGEON, WHEN HE REMOVED THE STEM FROM HE PATIENT'S BODY, HE NOTICED THAT IT IS DISCOLORED.

    Description of Event or Problem · 1

    SURGEON REPORTED THAT ON (B)(6) 2013, HE PERFORMED A REVISION SURGERY OF EXETER STEM IMPLANTED A FEW YEARS AGO. ACCORDING TO SURGEON, WHEN HE REMOVED THE STEM FROM HE PATIENT'S BODY, HE NOTICED THAT IT IS DISCOLORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78759 EXETER V40 STEM 44MM NO 2 IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH G1069549

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R