JOURNEY PFJ IMPLANT SM LT
Received Nov 13, 2017 · Event occurred Oct 30, 2017
Report 1020279-2017-01006 · MDR key 7023916
Device
Generic name
Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer
Manufacturer
Smith & Nephew, Inc.Catalog number
71461012
Lot number
10CM11723
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
74 YR
- Failure of Implant
- Failure of Implant
Narrative
Additional Manufacturer Narrative
[(B)(4)].
Additional Manufacturer Narrative
CORRECTIONS BASED ON NEW INFORMATION RECEIVED.
Description of Event or Problem
IT WAS ADDITIONALY REPORTED THAT THE COMPONENT WAS IN AN OPTIMAL POSITION ACCORDING TO THE SURGEON. THE RESON FOR REVISION SURGERY WAS PROGRESSIVE OA LEADING TO MEDIAL COMPARTMENT OA OF THE KNEE AND SURGEON CHOSE TO PERFORM A TOTAL KNEE REPLACEMENT DUE TO THE PATIENT¿S AGE.
Description of Event or Problem
IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY FOR UNSPECIFIED REASONS. KNEE CONVERTED TO TOTAL KNEE.