BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_SIZE 5 NEUTRAL LEFT ANATO STEM

    MDR report key: 7990662 · Received October 22, 2018

    Report

    Report Number
    0002249697-2018-03449
    Event Type
    Injury
    Date Received
    October 22, 2018
    Date of Event
    September 24, 2018
    Report Date
    December 18, 2018
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT REGARDING A PERIPROSTHETIC FRACTURE INVOLVING AN ACCOLADE STEM WAS REPORTED. THE EVENT WAS CONFIRMED BASED ON CLINICIAN REVIEW OF THE MEDICAL RECORDS PROVIDED. VISUAL INSPECTION OF THE RETURNED STEM COMPONENT WAS PERFORMED. THE STEM APPEARS CONSISTENT WITH AN EXPLANTED DEVICE WITH NOTHING REMARKABLE TO REPORT. A REVIEW OF THE PROVIDED MEDICAL RECORDS BY A CLINICAL CONSULTANT STATED THE FOLLOWING COMMENT: X-RAY CONFIRMS A PERIPROSTHETIC FEMORAL FRACTURE, NEED OPERATIVE REPORTS AND CLINICAL/PAST MEDICAL HISTORY. COULD NOT BE PERFORMED AS LOT CODE INFORMATION IS UNKNOWN. -COMPLAINT HISTORY REVIEW: COULD NOT BE PERFORMED AS LOT CODE INFORMATION IS UNKNOWN. A REVIEW OF THE PROVIDED MEDICAL RECORDS BY A CLINICAL CONSULTANT CONFIRMS A PERIPROSTHETIC FEMORAL FRACTURE. ADDITIONAL INFORMATION, INCLUDING LOT DETAILS, OPERATIVE REPORTS AND CLINICAL/PAST MEDICAL HISTORY ARE NEEDED TO FULLY INVESTIGATE THE EVENT. IF FURTHER INFORMATION BECOMES AVAILABLE, THIS INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT'S LEFT HIP WAS REVISED DUE TO A PERIPROSTHETIC FEMORAL FRACTURE (POSSIBLE CAUSE OR CONTRIBUTOR TO THE FRACTURE NOT REPORTED TO REP). AN ANATO STEM WAS REVISED TO AN OMNIFIT HFX STEM.

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT'S LEFT HIP WAS REVISED DUE TO A PERIPROSTHETIC FEMORAL FRACTURE (POSSIBLE CAUSE OR CONTRIBUTOR TO THE FRACTURE NOT REPORTED TO REP). AN ANATO STEM WAS REVISED TO AN OMNIFIT HFX STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830474 UNKNOWN_SIZE 5 NEUTRAL LEFT ANATO STEM HIP IMPLANT LZO STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R