BEUDAMED
    FDA Adverse Event Death Summary report: N

    HIP IMPLANT

    MDR report key: 9247987 · Received October 28, 2019

    Report

    Report Number
    1020279-2019-03767
    Event Type
    Death
    Date Received
    October 28, 2019
    Date of Event
    September 30, 2019
    Report Date
    November 12, 2019
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN ABSCESS IN HIS RIGHT HIP FLEXOR APPROXIMATELY A MONTH AFTER HIS SURGERY WHICH REQUIRED HOSPITALIZATION FOR 6 DAYS. THIS PATIENT PASSED AWAY IN 2015 AFTER RECEIVING TWO HIP IMPLANTS THAT WERE APPARENTLY DEFECTIVE. THERE IS NO CONFIRMATION THAT THE DEATH WAS CAUSED BY THE SMITH AND NEPHEW PRODUCTS.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN ABSCESS IN HIS RIGHT HIP FLEXOR APPROXIMATELY A MONTH AFTER HIS SURGERY. THIS PATIENT PASSED AWAY IN 2015. THERE IS NO CONFIRMATION THAT THE DEATH WAS CAUSED BY THE SMITH AND NEPHEW PRODUCTS. AS DEVICE DETAILS WERE NOT MADE AVAILABLE, DEVICE HISTORY RECORD AND COMPLAINT HISTORY REVIEW CANNOT BE COMPLETED. A RELATIONSHIP, IF ANY, BETWEEN THE DEVICES AND THE REPORTED INCIDENT OR ADVERSE EVENT COULD NOT BE CORROBORATED. A CLINICAL ANALYSIS NOTED THAT THE REPORTED ABSCESS WAS LIKELY RELATED TO THE PROCEDURE AS THE DEVICE FUNCTIONED WELL. THE PATIENT HAD SUCCESSFUL PHYSICAL THERAPY AND FUNCTIONED AND RETURNED TO ADL¿S FOLLOWING THE HOSPITALIZATION AND TREATMENT FOR THE ABSCESS. THE REPORT OF THE DEATH 2 YEARS AFTER THE IMPLANTATION. THE CERTIFICATE OF DEATH NOTES THE PATIENT¿S CAUSE OF DEATH WAS RESPIRATORY FAILURE AND PLEURAL EFFUSION AND NOT THE FAULT OF THE SMITH AND NEPHEW DEVICE ITSELF. HOWEVER, THE PATIENT¿S CHRONIC CONDITIONS AS CONTRIBUTING FACTORS CANNOT BE RULED OUT. NO FURTHER CLINICAL/MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. WITHOUT THE RETURN OF THE ACTUAL PRODUCT INVOLVED AND NO PRODUCT INFORMATION AVAILABLE, OUR INVESTIGATION OF THIS REPORT IS INCONCLUSIVE. NO FURTHER INVESTIGATION WARRANTED FOR THIS COMPLAINT; HOWEVER WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PASSED AWAY IN 2015 AFTER RECEIVING TWO HIP IMPLANTS THAT WERE APPARENTLY DEFECTIVE. THERE IS NO CONFIRMATION THAT THE DEATH WAS CAUSED BY THE SMITH AND NEPHEW PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1039505 HIP IMPLANT PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL JDH SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death