BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EXETER STEM 74 OF 123

    MDR report key: 8308884 · Received February 5, 2019

    Report

    Report Number
    0002249697-2019-00528
    Event Type
    Injury
    Date Received
    February 5, 2019
    Date of Event
    January 17, 2019
    Report Date
    February 5, 2019
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION IN THIS EVENT WAS INCLUDED IN THE QUARTERLY JOURNAL REVIEW CONDUCTED AT THE END OF THE Q4 2018. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE PROVIDED IN A FOLLOW UP REPORT. NOT RETURNED.

    Description of Event or Problem · 1

    THIS PI IS FOR THE 123 REVISIONS OF PATIENTS WITH EXETER STEMS DUE TO INSTABILITY. A REVIEW OF THE ARTICLE "MORE REOPERATIONS FOR PERIPROSTHETIC FRACTURE AFTER CEMENTED HA WITH POLISHED TAPER-SLIP STEMS: A STUDY FROM THE NORWEGIAN HIP FRACTURE REGISTER 2005 TO 2016" REVEALS THAT 461 PATIENTS WITH EXETER STEMS WERE REVISED. 123 OF THOSE REVISIONS OCCURRED DUE TO INSTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101872 UNKNOWN EXETER STEM 74 OF 123 HIP IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R