BEUDAMED
    FDA Adverse Event Death Summary report: N

    HIP IMPLANT

    MDR report key: 8434598 · Received March 19, 2019

    Report

    Report Number
    1020279-2019-01111
    Event Type
    Death
    Date Received
    March 19, 2019
    Date of Event
    February 22, 2019
    Report Date
    June 9, 2019
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CASE REPORTED A DEATH OF A PATIENT WHO UNDERWENT A HIP REPLACEMENT USING SMITH AND NEPHEW DEVICES. AFTER REPEATED REQUESTS, SMITH AND NEPHEW HAS BEEN UNABLE TO OBTAIN INFORMATION PERTAINING TO THE DEVICES ASSOCIATED WITH THE EVENT. SMITH AND NEPHEW HAS AN OUTSTANDING REQUEST WITH THE REPORTER FOR INFORMATION. AS DEVICE DETAILS WERE NOT MADE AVAILABLE, DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED. COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED DUE TO THE LACK OF PRODUCT INFORMATION. THE CAUSE OF DEATH IS UNKNOWN. A RELATIONSHIP, IF ANY, BETWEEN THE DEVICES AND THE REPORTED INCIDENT OR ADVERSE EVENT COULD NOT BE CORROBORATED. WITHOUT THE RETURN OF THE ACTUAL PRODUCT INVOLVED AND NO PRODUCT INFORMATION AVAILABLE, OUR INVESTIGATION OF THIS REPORT IS INCONCLUSIVE. OUR CLINICAL EVALUATION COULD NOT PERFORMED AT THIS TIME AS NO CLINICAL SUPPORTING DOCUMENTATION WAS PROVIDED. SHOULD CLINICAL DOCUMENTATION BECOMES AVAILABLE IN THE FUTURE, THE CLINICAL MEDICAL TASK MAY BE RE-EVALUATED. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT; HOWEVER, SMITH AND NEPHEW WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, THIS COMPLAINT WILL BE REOPENED AND REEVALUATED.

    Description of Event or Problem · 1

    A NEW LEGAL CLAIM WAS REPORTED DUE TO A DEATH THAT IS BELIEVED TO BE A DIRECT RESULT OF THE FAULTY DESIGN OF SMITH & NEPHEW HIP REPLACEMENT DEVICES. THE CAUSE OF DEATH IS UNKNOWN, AS ARE THE DEVICES INVOLVED, WHICH PART NUMBERS HAVE NOT BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227771 HIP IMPLANT PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL JDH SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death