JOURNEY PF IMPLANT MED RT
Received Dec 17, 2018 · Event occurred Nov 16, 2018
Report 1020279-2018-02816 · MDR key 8172067
Device
Generic name
Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer
Manufacturer
Smith & Nephew, Inc.Catalog number
71461015
Lot number
10CM10660
Product problems
- Break
- Break
Patient
Not reported
- Injury
- Injury
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION RECEIVED BY THE MANUFACTURER HAS IDENTIFIED THAT THIS EVENT SHOULD BE RE-EVALUATED FOR MDR REPORTING. THE NEW INFORMATION STATES THAT THIS EVENT HAS ALREADY BEEN REPORTED ON MDR 1020279-2018-02782, THEREFORE, IT WAS DETERMINED THAT THIS CASE DOES NOT MEET THE THRESHOLD FOR REPORTING AND IS A NON-REPORTABLE EVENT. IF FURTHER DETAILS ARE PROVIDED CONFIRMING THE OCCURRENCE OF A REPORTABLE EVENT, OUR FILES WILL BE UPDATED ACCORDINGLY AND A FURTHER REPORT SUBMITTED OUTLINING BOTH THE EVENT DETAILS AND OUR INVESTIGATIONS PERFORMED.
Additional Manufacturer Narrative
FURTHER EVALUATION OF THIS COMPLAINT DETERMINED THAT THIS RECORD IS A DUPLICATE OF AN EVENT THAT WAS PREVIOUSLY REPORTED TO FDA. THE EVENT IN THIS REPORT IS BEING ADDRESSED UNDER INTERNAL REFERENCE NUMBER (B)(4), WHICH HAS BEEN REPORTED ON MDR 1020279-2018-02782. INITIAL REPORT FOR RECORD (B)(4) WAS SENT TO FDA ON THU (B)(6) 2018. NO FURTHER INVESTIGATION WARRANTED FOR THIS COMPLAINT.
Description of Event or Problem
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED FOR A REPLACEMENT OF THE PARTIAL ENDOPROSTHESIS DUE TO A PROGRESSION OF OSTEOARTHRITIS IN THE RIGHT KNEE. IT WAS DISCOVERED THE COMPONENT WAS BROKEN.