FDA Adverse Event
Injury
Summary report: N
EVOLUTION®MP FEM
MDR report key: 21556178
·
Received March 9, 2025
Report
- Report Number
- 3010536692-2025-00130
- Event Type
- Injury
- Date Received
- March 9, 2025
- Report Date
- March 9, 2025
- Manufacturer
- MICROPORT ORTHOPEDICS INC.
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
ALLEGEDLY, EPRD REPORTED 1 NEW COMPLICATION FOR EVOLUTION® FEMORAL KNEE RE- REVISION (1 UNKNOWN). NO FURTHER INFORMATION WAS REPORTED. THIS INCIDENT IS CAPTURING 1 UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1233426 | EVOLUTION®MP FEM | KNEE COMPONENT | JWH | MICROPORT ORTHOPEDICS INC. | EFSRNXXX | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |