MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S3 RM
Received Oct 29, 2020 · Event occurred Sep 29, 2020
Report 3005180920-2020-00750 · MDR key 10755026
Device
Generic name
Anatomical Femoral Component
Manufacturer
Medacta International SaModel number
02.18.003RMCatalog number
02.18.003RM
Lot number
189249
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Pain
- Pain
Narrative
Additional Manufacturer Narrative
BATCH REVIEW PERFORMED ON (B)(6) 2020. LOT 189249: 48 ITEMS MANUFACTURED AND RELEASED ON 13-MAR-2019. EXPIRATION DATE: 02-MAR-2024. NO ANOMALIES FOUND RELATED TO THE PROBLEM TO DATE, 46 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. OTHER DEVICE INVOLVED IN THE EVENT. MOTO PARTIAL KNEE 02.18.TF4.RM TIBIAL TRAY FIX CEMENTED S4 RM LOT. 189256 (K162084). BATCH REVIEW PERFORMED ON (B)(6) 2020. LOT 189256: 50 ITEMS MANUFACTURED AND RELEASED ON 27-FEB-2019. EXPIRATION DATE: 17-FEB-2024. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 41 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. MOTO PARTIAL KNEE 02.18.IF4.09.RM TIBIAL INSERT FIX S4 RM - 9MM LOT. 189282 (K162084) BATCH REVIEW PERFORMED ON (B)(6) 2020. LOT 189282: 35 ITEMS MANUFACTURED AND RELEASED ON 09-APR-2019. EXPIRATION DATE: 26-MAR-2024. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 26 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.
Description of Event or Problem
THE PATIENT CAME IN REPORTING PAIN 11 MONTHS AFTER THE PRIMARY SURGERY. THE SURGEON REVISED ALL MOTO IMPLANTS TO SPHERE IMPLANTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.