BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE STEM

    MDR report key: 7732935 · Received July 30, 2018

    Report

    Report Number
    0002249697-2018-02366
    Event Type
    Injury
    Date Received
    July 30, 2018
    Date of Event
    June 20, 2018
    Report Date
    August 29, 2018
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: UNKNOWN MITCH DEVICE; CAT# UNKNOWN; LOT# FM 063852; STD MITCH TRH CP SZ 48/54; CAT# MAC-9988-4854; LOT# FM 60401 011. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. AN EVENT REGARDING ALTR AND OSTEOLYSIS INVOLVING AN UNKNOWN ACCOLADE STEM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. MEDICAL RECORDS RECEIVED AND EVALUATION: NO INFORMATION WAS RECEIVED FOR REVIEW WITH THE CLINICAL CONSULTANT. DEVICE HISTORY REVIEW COULD NOT BE PERFORMED AS THE DEVICE LOT IS UNKNOWN. COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED AS THE DEVICE LOT IS UNKNOWN. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS DEVICE DETAILS, RETURN OF DEVICE, OPERATIVE REPORTS, X-RAYS, PATIENT HISTORY & FOLLOW-UP NOTES ARE NEEDED TO INVESTIGATE THIS EVENT FURTHER. IF ADDITIONAL INFORMATION AND/OR DEVICE BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 0

    PATIENT HAS A PSEUDO TUMOR, METALLOSIS OSTEOLYSIS AND HAD AN ACCOLADE DONE IN (B)(6) 2007. REVISION SURGERY COMPLETED ON (B)(6) 2018.

    Additional Manufacturer Narrative · 1

    THE OTHER DEVICE LISTED IN THIS REPORT: CAT # UNKNOWN, LOT # UNKNOWN, DESCRIPTION: UNKNOWN MITCH HEAD, MANUFACTURER: DEPUY. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    PATIENT HAS A PSEUDO TUMOR, METALLOSIS OSTEOLYSIS AND HAD AN ACCOLADE DONE IN (B)(6) 2007. REVISION SURGERY COMPLETED ON (B)(6) 2018

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574609 ACCOLADE STEM HIP IMPLANT LZO STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R