BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIFIT M/S PSL SHELL 48MM

    MDR report key: 4140334 · Received October 3, 2014

    Report

    Report Number
    0002249697-2014-03732
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 8, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K903636
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION WAS REQUESTED AND IF IT BECOMES AVAILABLE WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION: INSPECTION OF THE PROVIDED PHOTO REGARDING THE SHELL CAN CONFIRM WEAR ON THE RIM OF THE SHELL LIKELY DUE TO DISLOCATION. DURING THE INVESTIGATION IT WAS DETERMINED THAT THE SHELL HAD LOOSENED. THE EVENT WAS CONFIRMED BUT THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS REPORTED FOR THE REPORTED MANUFACTURING LOT X-RAYS CONFIRM DISLOCATED HIP WITH LOOSE ACETABULAR. NEED CLINICAL HISTORY, OPERATIVE REPORTS AND PROGRESS NOTES. DURING THE INVESTIGATION IT WAS DETERMINED THAT THE SHELL HAD LOOSENED. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE OF THE REPORTED EVENT DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    UPDATE: AS PER X-RAY IMAGE, THE SHELL DISASSOCIATED FROM THE STEM.

    Description of Event or Problem · 1

    UPDATE: AS PER X-RAY IMAGE, THE SHELL DISASSOCIATED FROM THE STEM.

    Description of Event or Problem · 1

    REVISION OF TOTAL HIP REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619133 OMNIFIT M/S PSL SHELL 48MM IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH ML3108

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention