FDA Adverse Event
Injury
Summary report: N
EVOLUTION MP CS INSERT SIZE 7 STANDARD 10MM LEFT
MDR report key: 9836007
·
Received March 16, 2020
Report
- Report Number
- 3010536692-2020-00241
- Event Type
- Injury
- Date Received
- March 16, 2020
- Report Date
- October 14, 2020
- Manufacturer
- MICROPORT ORTHOPEDICS INC.
- Product Code
- HRY
- UDI-DI
- M684EIS7S10L1
- PMA / PMN Number
- K093552
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT WILL BE UPDATED ONCE THE INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATE.
Description of Event or Problem · 1
ALLEGEDLY, PATIENT WAS REVISED DUE TO KNEE TIGHTNESS AND INABILITY TO PERFORM FLEXION. SOFT TISSUES REMOVED AND LINER EXCHANGED WITH THE SAME SIZE LINER. PRODUCT NO REVISED: ADVANCE EVOLUTION PRODUCT ID: K0001288 , LOT # 1746398, QTY 2. EVOLUTION FEMORAL PRODUCT ID: EFSRN7PL, LOT # 1776909. EVOLUTION TIBIAL PRODUCT ID: ETPKN7SL, LOT # 1766941.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 299443 | EVOLUTION MP CS INSERT SIZE 7 STANDARD 10MM LEFT | KNEE COMPONENT | HRY | MICROPORT ORTHOPEDICS INC. | EIS7S10L | 1767643 | M684EIS7S10L1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |