BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTERTAN 10MM X 20CM 125D

    MDR report key: 6926338 · Received October 7, 2017

    Report

    Report Number
    1020279-2017-00837
    Event Type
    Death
    Date Received
    October 7, 2017
    Date of Event
    August 29, 2017
    Report Date
    April 3, 2018
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDS
    UDI-DI
    03596010565372
    PMA / PMN Number
    K040212
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASSOCIATED COMPLAINT DEVICES WERE NOT RETURNED FOR EVALUATION. ON POST OP DAY ONE AFTER A TOTAL HIP ARTHROPLASTY, IT WAS REPORTED THAT THE PATIENT DIED DUE TO NATURAL CAUSES. ADDITIONAL CLINICAL INFORMATION RELATED TO THIS CASE HAS BEEN REQUESTED BUT NOT PROVIDED. A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL ANY MANUFACTURING OR MATERIAL ABNORMALITIES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. A REVIEW OF COMPLAINT HISTORY ON THE REPORTED PARTS REVEALED NO ADDITIONAL COMPLAINTS FOR THE LISTED BATCHES. WITHOUT THE PATIENT¿S MEDICAL HISTORY, COMORBIDITIES, AND OTHER RELEVANT MEDICAL INFORMATION, THE ROOT CAUSE OF THE PATIENT¿S DEMISE CANNOT BE DETERMINED. BASED ON A REVIEW OF THE LIMITED DETAILS PROVIDED WITH THIS CASE, A CAUSAL RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED DEATH CANNOT BE ESTABLISHED. IF ADDITIONAL RELEVANT SUPPORTING DOCUMENTS ARE RECEIVED, THIS CASE CAN BE RE-EVALUATED. NO FURTHER CLINICAL ASSESSMENT IS WARRANTED AT THIS TIME. HOWEVER, WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. WE CONSIDER THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A HIP BREAKAGE OPERATION, 1 DAY AFTER THE OPERATION PATIENT DIED. ALTHOUGH PATIENT REPORT STATES IT WAS A NATUREL DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705912 INTERTAN 10MM X 20CM 125D NAIL, FIXATION, BONE JDS SMITH & NEPHEW, INC. 17ET87233 03596010565372

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death