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