BEUDAMED
    FDA Adverse Event Death Summary report: N

    EXETER V40(TM). FEM. STEM 44MM

    MDR report key: 21490697 · Received February 28, 2025

    Report

    Report Number
    0002249697-2025-00249
    Event Type
    Death
    Date Received
    February 28, 2025
    Date of Event
    January 30, 2025
    Report Date
    July 23, 2025
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    UDI-DI
    04546540153418
    PMA / PMN Number
    K011623
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: DEVICE DETAILS (CAT#, GTIN, PRODUCT CODE, COMMON DEVICE NAME). AN EVENT REGARDING PATIENT FACTORS (PULMONARY EMBOLISM) INVOLVING A 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 CLINICAL CONSULTANT. PRODUCT HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. CONCLUSIONS: IT WAS REPORTED THAT DURING THE SURGERY, AFTER THE CUP PLACEMENT WAS COMPLETED AND THE STEM ON THE FEMORAL SIDE WAS BEING RE-REPLACED (THE SALES COMMENT WAS, "THE SURGICAL FIELD DID NOT LOOK CLEAR, SO THIS IS JUST SPECULATION, BUT WE THINK IT WAS WHEN WE WERE REMOVING THE SOFT TISSUE"), THE PATIENT'S ELECTROCARDIOGRAM SUDDENLY SHOWED ABNORMAL WAVEFORMS AND HER CONDITION SUDDENLY WORSENED. THE EXACT CAUSE COULD NOT BE DETERMINED AS INSUFFICIENT INFORMATION WAS PROVIDED. 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. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    REVISION THA WAS PERFORMED ON (B)(6) 2025 TO REPLACE THE IMPLANT DEVICES (COMPETITOR PRODUCTS) WITH NEW ONES (STRYKER'S PRODUCTS) BECAUSE OF THE NECK FRACTURE OF THE COMPETITOR STEM. THE CUP WAS REPLACED SUCCESSFULLY, AND THE SURGEON BEGAN TO REPLACE THE STEM AS A NEXT STEP. HOWEVER, DURING STEM REPLACEMENT, THE PATIENT'S ELECTROCARDIOGRAM SUDDENLY SHOWED ABNORMAL WAVEFORMS AND HER CONDITION WORSENED. ALTHOUGH IT WAS NOT CONFIRMED PROPERLY, THE ANESTHESIOLOGIST WHO PARTICIPATED IN THE OPERATION STATED "IT'S A PULMONARY EMBOLISM" DURING A LIFESAVING PROCEDURE OF THE SUDDEN CHANGE IN THE PATIENT'S CONDITION, SO THERE IS A POSSIBILITY THAT THE PATIENT WENT INTO CARDIAC ARREST DUE TO A PULMONARY EMBOLISM. AS THE PATIENT WENT INTO CARDIAC ARREST, THE SURGERY DISCONTINUED, AND THE PATIENT MANAGED TO REGAIN CONSCIOUSNESS ON THE SAME DAY THROUGH 30 MINUTES OF CARDIAC MASSAGE AND ECMO. THE PATIENT'S FINAL OUTCOME AFTER REGAINING CONSCIOUSNESS IS UNKNOWN. IT WAS REPORTED THAT THE PATIENT HAD NO ABNORMALITIES SUCH AS PRIMARY DISEASE AT THE TIME OF SURGERY OTHER THAN STEM NECK FRACTURE. UPDATE: PATIENT DIED ON (B)(6) 2025 DUE TO A PULMONARY EMBOLUS.

    Description of Event or Problem · 0

    REVISION THA WAS PERFORMED ON (B)(6) 2025 TO REPLACE THE IMPLANT DEVICES (COMPETITOR PRODUCTS) WITH NEW ONES (STRYKER'S PRODUCTS) BECAUSE OF THE NECK FRACTURE OF THE COMPETITOR STEM. THE CUP WAS REPLACED SUCCESSFULLY, AND THE SURGEON BEGAN TO REPLACE THE STEM AS A NEXT STEP. HOWEVER, DURING STEM REPLACEMENT, THE PATIENT'S ELECTROCARDIOGRAM SUDDENLY SHOWED ABNORMAL WAVEFORMS AND HER CONDITION WORSENED. ALTHOUGH IT WAS NOT CONFIRMED PROPERLY, THE ANESTHESIOLOGIST WHO PARTICIPATED IN THE OPERATION STATED, "IT'S A PULMONARY EMBOLISM" DURING A LIFESAVING PROCEDURE OF THE SUDDEN CHANGE IN THE PATIENT'S CONDITION, SO THERE IS A POSSIBILITY THAT THE PATIENT WENT INTO CARDIAC ARREST DUE TO A PULMONARY EMBOLISM. AS THE PATIENT WENT INTO CARDIAC ARREST, THE SURGERY DISCONTINUED, AND THE PATIENT MANAGED TO REGAIN CONSCIOUSNESS ON THE SAME DAY THROUGH 30 MINUTES OF CARDIAC MASSAGE AND ECMO. THE PATIENT'S FINAL OUTCOME AFTER REGAINING CONSCIOUSNESS IS UNKNOWN. IT WAS REPORTED THAT THE PATIENT HAD NO ABNORMALITIES SUCH AS PRIMARY DISEASE AT THE TIME OF SURGERY OTHER THAN STEM NECK FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810173 EXETER V40(TM). FEM. STEM 44MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI STRYKER ORTHOPAEDICS-MAHWAH G8530397 04546540153418

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention| O| D