BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3171350 · Received June 14, 2013

    Report

    Report Number
    0002249697-2013-01923
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 20, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING ALLEGED CRACK/FRACTURE INVOLVING A TRIDENT LINER WAS REPORTED. THE EVENT WAS CONFIRMED. THE FRAGMENTS OF THE RETURNED ALUMINA INSERT OF THE TRIDENT ALUMINA INSERT/SLEEVE ASSEMBLY MAKE UP LESS THAN 40% OF THE INSERT. THE FRACTURE SURFACES OF THE INSERT WERE EXAMINED WITH THE AID OF A STEREOMICROSCOPE AT MAGNIFICATIONS UP TO 50X. NOTHING COULD BE LEARNED ABOUT THE CAUSE OF FRACTURE DUE TO FRACTURE SURFACE DAMAGE THAT OCCURRED POST FRACTURE THE MATERIAL ANALYSIS REPORT CONCLUDED THAT NOTHING COULD BE LEARNED ABOUT THE FRACTURE OF THE ALUMINA INSERT OF THE TRIDENT ALUMINA INSERT/SLEEVE ASSEMBLY BECAUSE NONE OF THE FRAGMENTS EXAMINED CONTAINED THE PRIMARY FRACTURE SURFACE OR THE FRACTURE ORIGIN. DAMAGE TO THE INSIDE DIAMETER OF THE SLEEVE OF THE TRIDENT ALUMINA INSERT/SLEEVE ASSEMBLY AND THE ALUMINA HEAD WERE CAUSED AFTER FRACTURE OF THE INSERT FROM CONTACT WITH THE FRAGMENTS OF THE BROKEN INSERT. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON THE COMPONENTS EXAMINED. INSUFFICIENT INFORMATION WAS RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. DEVICE HISTORY REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW INDICATED THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. THE EXACT ROOT CAUSE COULD NOT BE DETERMINED AS NOTHING COULD BE LEARNED ABOUT THE FRACTURE OF THE ALUMINA INSERT OF THE TRIDENT ALUMINA INSERT/SLEEVE ASSEMBLY BECAUSE NONE OF THE FRAGMENTS EXAMINED CONTAINED THE PRIMARY FRACTURE SURFACE OR THE FRACTURE ORIGIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON REVISED PATIENT'S CERAMIC ON CERAMIC LEFT HIP FOR UNKNOWN REASON AT THIS TIME. SALES REP STATED THAT THE 32 CERAMIC HEAD WAS MIS-SHAPED WHEN EXPLANTED AND THE CERAMIC LINER CAME OUT IN PIECES. PATIENT HAD A MERIDIAN STEM THAT REMAINED IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON REVISED PATIENT'S CERAMIC ON CERAMIC LEFT HIP FOR UNKNOWN REASON AT THIS TIME. SALES REP STATED THAT THE 32 CERAMIC HEAD WAS MIS-SHAPED WHEN EXPLANTED AND THE CERAMIC LINER CAME OUT IN PIECES. PATIENT HAD A MERIDIAN STEM THAT REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271111 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 19386801

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| O| R