SAIPH CEMENTED PATELLA
Received Oct 24, 2025 · Event occurred Oct 13, 2025
Report 3016096064-2025-00001 · MDR key 23376983
Product problems
- Break
- Break
Patient
NA · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THIS IS THE FIRST INSTANCE OF THIS KIND OF FAILIURE THERE HAVE BEEN NO OTHER SIMILAR REPORTS BEFORE OR SINCE, BATCH RECORDS WERE REVIEWED AND THERE WERE NO REPORTED ISSUES ON THE DOCUMENTATION.
Description of Event or Problem
ATTENDED A REVISON CASE FOR A PATELLA WHICH WAS IMPLANTED ON (B)(6) 2017 BY DR (B)(6). THE PATELLA RECENTLY / POTENTIALLY EXPERIENCED A SHEAR FORCE OF UNKNOWN CIRCUMSTANCE LEADING TO THE PATELLA BUTTON BEING BROKEN OFF FROM ITS POLY PEGS/STEMS WITH THE PEGS REMAINING INTACT WITHIN THE BONE. DR (B)(6) THEREFORE BOOKED THE PATIENT IN FOR A REVISON OF THE PATELLA BUTTON AND REPLACED THE PATELLA ON (B)(6) 25 WITH ANOTHER 34MM CEMENTED SAIPH PATELLA.