BEUDAMED
    FDA Adverse Event Death Summary report: N

    EXETER V40 STEM 44MM NO 2

    MDR report key: 7582126 · Received June 8, 2018

    Report

    Report Number
    0002249697-2018-01750
    Event Type
    Death
    Date Received
    June 8, 2018
    Date of Event
    May 14, 2018
    Report Date
    August 29, 2018
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K173499
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: CATALOG: 2030-6516-1 DESCRIPTION: 6.5 CANCELLOUS BONE SCREW 16MM VD5JR4; CATALOG: 2030-6516-1 DESCRIPTION: 6.5 CANCELLOUS BONE SCREW 16MM H96YPL; CATALOG: 2060-0000-1 DESCRIPTION: ACETABULAR DOME HOLE PLUG PW51YP; CATALOG: 2030-6516-1 DESCRIPTION: 6.5 CANCELLOUS BONE SCREW 16MM TJ8Y15; CATALOG: 2030-6516-1 DESCRIPTION: 6.5 CANCELLOUS BONE SCREW 16MM V003Y5. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. AN EVENT REGARDING DEATH OF A PATIENT INVOLVING AN EXETER STEM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: PRODUCT EVALUATION AND RESULTS: NOT PERFORMED AS THE DEVICE WAS NOT RETURNED. MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS NO MEDICAL RECORDS WERE RETURNED FOR REVIEW. PRODUCT HISTORY REVIEW: A REVIEW OF THE DEVICE MANUFACTURING RECORDS INDICATE THAT ALL DEVICES ACCEPTED INTO FINAL STOCK WERE FREE FROM DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE WERE NO OTHER EVENTS FOR THE LOT PROVIDED. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS CAUSE OF DEATH, DEVICE RETURN, PATHOLOGY REPORTS, PRE-OPERATIVE X-RAYS AND THE PRIMARY OPERATIVE REPORT AS WELL AS PATIENT HISTORY ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. ADDITIONAL DEVICES LISTED IN THIS EVENT: CATALOG: 508-11-56F DESCRIPTION: TRIDENT HEMISPHERICAL MULTI TRIDENT CUP LOT: 63742601, CATALOG: 6570-0-132 DESCRIPTION: DELTA V-40 CERAMIC HEAD 32/0 LOT: 62714702, CATALOG: 623-10-32F DESCRIPTION: TRIDENT 10° X3 INSERT 32MM ID LOT: X4458Y. NOT RETURNED.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT THA SURGERY AFTER PELVIC FRACTURE WITH TRIDENT CUP, EXETER AND COMPETITORS' CEMENT ON (B)(6) 2018. AFTER THE SURGERY, AND WHEN TRYING TO CHANGE THE PATIENT'S BODY POSITION, THE PATIENT'S CONDITION WORSENED. THE PATIENT ONCE RECOVERED BY HEART MASSAGE ETC. BUT HE DIED. ADDITIONAL INFORMATION CONFIRMED THIS IS A PRIMARY SURGERY DUE TO A PELVIC FRACTURE. ADDITIONAL INFORMATION STATES: 'THE CAUSE OF DEATH IS UNKNOWN. THERE IS THE CAUSAL RELATIONSHIP WITH THE PROCEDURE BUT THE CAUSAL RELATIONSHIP WITH THE PRODUCT IS UNKNOWN.'

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT THA SURGERY AFTER PELVIC FRACTURE WITH TRIDENT CUP, EXETER AND COMPETITORS' CEMENT ON (B)(6) 2018. AFTER THE SURGERY, AND WHEN TRYING TO CHANGE THE PATIENT'S BODY POSITION, THE PATIENT'S CONDITION WORSENED. THE PATIENT ONCE RECOVERED BY HEART MASSAGE ETC. BUT HE DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426068 EXETER V40 STEM 44MM NO 2 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI STRYKER ORTHOPAEDICS-MAHWAH G7264194

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Death