JOURNEY PFJ IMPLANT X-SM RT
Received Mar 18, 2019 · Event occurred Feb 22, 2019
Report 1020279-2019-01084 · MDR key 8429570
Device
Generic name
Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer
Manufacturer
Smith & Nephew, Inc.Catalog number
71461011
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
Not reported
- Injury
- Injury
Narrative
Additional Manufacturer Narrative
THE ASSOCIATED COMPLAINT DEVICE WAS NOT RETURNED. THE CLINICAL/MEDICAL TEAM CONCLUDED, NO CLINICAL SUPPORTING DOCUMENTS WERE PROVIDED TO CONDUCT A THOROUGH ASSESSMENT OF THE REPORTED ISSUE. WITHOUT THE ACTUAL DEVICE INVOLVED OUR INVESTIGATION CANNOT PROCEED. IF THE DEVICE OR NEW INFORMATION IS RECEIVED IN THE FUTURE, THE COMPLAINTS CAN BE RE-OPENED. NO FURTHER ACTIONS ARE BEING TAKEN AT THIS TIME. WE CONSIDER THIS INVESTIGATION CLOSED.
Description of Event or Problem
IT WAS REPORTED THAT THE IMPLANT WAS REVISED DUE TO DISEASE PROGRESSION, NOT IMPLANT FAILURE. NO MORE INFORMATION AVAILABLE.