BEUDAMED
    FDA Adverse Event Death Summary report: N

    REDAPT FULLY POROUS SHELL 68MM

    MDR report key: 10147104 · Received June 12, 2020

    Report

    Report Number
    1020279-2020-02345
    Event Type
    Death
    Date Received
    June 12, 2020
    Date of Event
    October 1, 2016
    Report Date
    February 5, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    LPH
    PMA / PMN Number
    K150790
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE USED IN TREATMENT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE ACTUAL PRODUCT, PRODUCT EVALUATION COULD NOT BE PERFORMED AND COMPLAINT COULD NOT BE CONFIRMED. ACCORDING TO CLINICAL/MEDICAL INVESTIGATION, THESE CASES FROM CANADA ALL REPORT VARIOUS ADVERSE EVENTS WITH THE REDAPT IMPLANTS. ALL INFORMATION AVAILABLE FOR THIS COMPLAINT CASE HAS BEEN REVIEWED AND CONSIDERED IN THE MEDICAL ASSESSMENT. WITHOUT SUPPORTING CLINICAL/MEDICAL DOCUMENTS, A THOROUGH INVESTIGATION CANNOT BE PERFORMED. SHOULD INFORMATION BECOME AVAILABLE THIS COMPLAINT CAN BE RE-ASSESSED. A REVIEW OF COMPLAINT HISTORY REVEALED NO PRIOR COMPLAINTS FOR THE LISTED PART. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCTS FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. INFECTION, A POTENTIAL COMPLICATION ASSOCIATED WITH ANY SURGERY, CAN OCCUR AND POSSIBLE CAUSES COULD INCLUDE BUT NOT LIMITED TO CONTAMINATION, PATIENT REACTION, AND POST-OPERATIVE HEALING ISSUE. A REVIEW OF RISK MANAGEMENT FILES AND THE INSTRUCTIONS FOR USE FOUND THAT THE REPORTED FAILURE WAS DOCUMENTED APPROPRIATELY. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. NO FURTHER ACTIONS ARE BEING TAKEN AT THIS TIME. WE CONSIDER THIS INVESTIGATION CLOSED. CREDIT WILL NOT BE ISSUED FOR THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DETERIORATED AFTER THE I&D OF HIS HIP. AFTER THAT, THE PATIENT DEVELOPED A CHRONIC PERIPROSTHETIC INFECTION THAT LED TO SEPSIS AND EVENTUALLY DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611432 REDAPT FULLY POROUS SHELL 68MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH SMITH & NEPHEW, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death