BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN JOURNEY BCS / JOURNEY II BCS KNEE

    MDR report key: 10255948 · Received July 9, 2020

    Report

    Report Number
    1020279-2020-03039
    Event Type
    Injury
    Date Received
    July 9, 2020
    Date of Event
    April 11, 2020
    Report Date
    April 8, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT KNEE SURGERY FOR A PROSTHESIS ON THE RIGHT KNEE IN 2008 AND STARTED EXPERIENCING ITERATIVE DISLOCATIONS 3 MONTHS AGO, WHILE HYPER FLEXING SUCH KNEE. A REVISION SURGERY WAS PLANNED ON (B)(6) 2020. THE AFFECTED COMPLAINT DEVICE, USED IN TREATMENT, WAS NOT RETURNED FOR EVALUATION. THEREFORE A PRODUCT ANALYSIS COULD NOT BE PERFORMED. AS DEVICE INFORMATION WAS NOT MADE AVAILABLE, DEVICE HISTORY RECORD AND COMPLAINT HISTORY REVIEW CANNOT BE COMPLETED. THERE IS NO INFORMATION THAT WOULD SUGGEST THE DEVICE FAILED TO MEET SPECIFICATIONS. A RELATIONSHIP, IF ANY, BETWEEN THE DEVICE AND THE REPORTED INCIDENT COULD NOT BE CORROBORATED. NO MEDICAL DOCUMENTS WERE RECEIVED FOR INVESTIGATION. THEREFORE NO MEDICAL ASSESSMENT CAN BE PERFORMED AT THIS TIME. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. A REVIEW OF RISK MANAGEMENT FILES FOUND THAT THE REPORTED FAILURE WAS DOCUMENTED APPROPRIATELY. SOME POTENTIAL CAUSES COULD INCLUDE BUT ARE NOT LIMITED TO TRAUMATIC INJURY OR PATIENT CONDITIONS. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT; HOWEVER WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT, WHO HAD UNDERGONE KNEE SURGERY FOR A PROSTHESIS ON THE RIGHT KNEE IN (B)(6) 2008, STARTED EXPERIENCING ITERATIVE DISLOCATIONS THREE MONTHS AGO WHILE HYPER-FLEXING SUCH KNEE. A REVISION SURGERY WILL BE PERFORMED TO CORRECT THE ISSUE. THE PATIENT'S HEALTH STATUS IS UNKNOWN AT THIS POINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719542 UNKN JOURNEY BCS / JOURNEY II BCS KNEE PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH SMITH & NEPHEW, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R