BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIZE 3 ACCOLADE II 127 DEG

    MDR report key: 11799014 · Received May 10, 2021

    Report

    Report Number
    0002249697-2021-00820
    Event Type
    Death
    Date Received
    May 10, 2021
    Date of Event
    April 12, 2021
    Report Date
    May 10, 2021
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    UDI-DI
    04546540669483
    PMA / PMN Number
    K143085
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PATIENT FACTORS INVOLVING AN ACCOLADE STEM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS:  DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS PRODUCT WAS NOT RETURNED. CLINICIAN REVIEW: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. DEVICE HISTORY REVIEW: INDICATED ALL DEVICES ACCEPTED INTO FINAL STOCK FROM THE REPORTED LOT WERE FREE FROM DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. CONCLUSION: THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS RETURN OF THE DEVICE, PRE- AND POST-OPERATIVE X-RAYS, PRIMARY OPERATIVE REPORT AS WELL AS PATIENT HISTORY AND FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOME AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED. NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    ALTHOUGH CARDIAC ARREST HAPPENED DURING PROCEDURE, BUT PATIENT WAS RESUSCITATED AND TRANSFERRED TO ANOTHER HOSPITAL. HE DIED AFTER ABOUT 24 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699285 SIZE 3 ACCOLADE II 127 DEG PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH 6721-0330 81793203 04546540669483

    Patients

    Seq Age Sex Outcome Treatment
    1 76 Death