FDA Adverse Event
Malfunction
Summary report: N
MOTO PARTIAL KNEE SYSTEM - MEDIAL
MDR report key: 22781806
·
Received August 12, 2025
Report
- Report Number
- 3005180920-2025-00823
- Event Type
- Malfunction
- Date Received
- August 12, 2025
- Date of Event
- July 21, 2025
- Report Date
- August 12, 2025
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- HSX
- UDI-DI
- 07630030896101
- PMA / PMN Number
- K162084
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 28 JULY 2025. LOT 2426815: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09/11/2024. EXPIRATION DATE: 23/10/2029. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 27 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.
Description of Event or Problem · 0
TIBIAL INSERT 8MM COULD NOT BE COUPLED WITH THE TIBIAL TRAY; 9MM INSERT WAS USED AND THE SURGERY WAS COMPLETED SUCCESSFULLY. NO TIBIA RECUT NEEDED. THE SURGERY WAS PROLONGED BY ABOUT 20 MINUTES. DEVICES COUPLED IN BACKTABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1887959 | MOTO PARTIAL KNEE SYSTEM - MEDIAL | TIBIAL INSERT FIX S4 RM - 8MM | HSX | MEDACTA INTERNATIONAL SA | 02.18.IF4.08.RM | 2426815 | 07630030896101 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Male | Other |