BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3140281 · Received May 31, 2013

    Report

    Report Number
    0002249697-2013-01815
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 6, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K994366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE WERE NO SIMILAR EVENTS FOR THE REPORTED LOT. THE EVENT COULD NOT BE CONFIRMED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS AVAILABLE REGARDING THE CAUSE OF THE APPARENT FAILURE OF PERIPROSTHETIC FRACTURE. MORE CLINICAL INFORMATION WOULD BE HELPFUL TO RULE OUT POSSIBLE CONTRIBUTORY FACTORS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER IS UNKNOWN AT THIS TIME. THE DEVICE WAS REPORTED AS AN UNKNOWN ACCOLADE TMZF STEM. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELL AND SUSTAINED A PERIPROSTHETIC FRACTURE FROM THE ORIGINAL BIPOLAR HIP SO THE SURGEON REVISED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELL AND SUSTAINED A PERIPROSTHETIC FRACTURE FROM THE ORIGINAL BIPOLAR HIP SO THE SURGEON REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242363 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 39052402

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Other| R