BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_EXETER STEM

    MDR report key: 16642830 · Received March 30, 2023

    Report

    Report Number
    0002249697-2023-00330
    Event Type
    Injury
    Date Received
    March 30, 2023
    Date of Event
    March 7, 2023
    Report Date
    April 28, 2023
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: AN EVENT REGARDING CRACK/FRACTURE INVOLVING AN UNKNOWN EXETER STEM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: PRODUCT EVALUATION AND RESULTS: MATERIAL ANALYSIS, VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTIONS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. CLINICIAN REVIEW: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. PRODUCT HISTORY REVIEW: COULD NOT BE PERFORMED AS THE DEVICE LOT DETAILS WERE NOT PROVIDED. COMPLAINT HISTORY REVIEW: COULD NOT BE PERFORMED AS THE DEVICE LOT DETAILS WERE NOT PROVIDED. CONCLUSIONS: IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO FRACTURE OF THE EXETER STEM. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS RETURN OF THE DEVICE, PATHOLOGY REPORTS, PRE- AND POST-OPERATIVE X-RAYS AND THE REVISION 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 DEVICES AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Additional Manufacturer Narrative · 0

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED: A BROKEN EXETER STEM THAT WAS REVISED. UPDATE - WHAT IS THE REASON FOR THE REVISION (WHAT EVENT LED UP TO THE STEM SNAPPING)? "THE STEM JUST SNAPPED, HE WAS FINE UNTIL THEN. FATIGUE FAILURE. WAS A 44/2 DONE IN 2009. 36 ALUMINA HEAD." IS THE EXPLANTED DEVICE IS AVAILABLE FOR ASSESSMENT? ¿ NO, HAS BEEN DISPOSED OF. "NO ITS IN THE BIN!"

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED: A BROKEN EXETER STEM THAT WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177654 UNKNOWN_EXETER STEM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H