BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_CORK_PRODUCT

    MDR report key: 4093533 · Received September 16, 2014

    Report

    Report Number
    0002249697-2014-03491
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    March 14, 2014
    Report Date
    August 30, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATALOG NUMBER AND LOT CODE OF THE FEMORAL STEM EXPLANTED WERE NOT PROVIDED. AN UNKNOWN MITCH HEAD AND CUP (BOTH MANUFACTURED BY DEPUY) WERE ALSO NOTED IN THIS REPORT. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA THE CLINICAL RESEARCH MANAGER THAT A PATIENT UNDERWENT A REVISION SURGERY OF THEIR MITCH PER HIP REPLACEMENT DUE TO LATE FEMORAL NECK FRACTURE POST RESURFACING. THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2008. THE CUSTOMER REPORTED THAT THE ACETABULAR COMPONENT WAS REVISED AND REPLACED WITH A 64MM UNCEMENTED TRIDENT ACETABULAR CUP WITH A 36MM X3 POLYETHYLENE BEARING AND THE FEMORAL HEAD WAS REVISED TO A 36MM MEDIUM CERAMIC FEMORAL HEAD. THE CUSTOMER INDICATED IN THE ADVERSE INCIDENT REPORT THAT THE EXPLANT IS NOT AVAILABLE FOR INVESTIGATION ALTHOUGH NO FURTHER EXPLANATION WAS GIVEN. THE ADVERSE INCIDENT REPORT INDICATES THAT THERE WAS NO FLUID COLLECTION IN THE JOINT AND NO SIGN OF METALLOSIS. FURTHERMORE, THE CUSTOMER REPORTED THAT THE OLD FEMORAL COMPONENT WAS STABLE AND THEREFORE LEFT IN SITU. THE PATIENT WAS A SUBJECT IN A CLINICAL STUDY RUN BY THE HOSPITAL (PATIENT ID: (B)(6) PER SURVEILLANCE STUDY). UPDATE (B)(6) 2014: - THE CUSTOMER REPORTED THAT THE FEMORAL STEM WAS ALSO REVISED TO AN EXETER V40 CEMENTED STEM (OFFSET 44, NO. 2). THE PRIMARY PROCEDURE WAS PERFORMED AT A DIFFERENT HOSPITAL AND THEREFORE THE HOSPITAL IS STRUGGLING TO PROVIDE PRODUCT AND LOT CODES FOR THE PRIMARY DEVICES. THEY BELIEVE THE EXPLANTS WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572719 UNKNOWN_CORK_PRODUCT IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R