FDA Adverse Event
Injury
Summary report: N
EVOLUTION®MP FEM CS/CR POROUS
MDR report key: 20983925
·
Received December 19, 2024
Report
- Report Number
- 3010536692-2024-00503
- Event Type
- Injury
- Date Received
- December 19, 2024
- Date of Event
- November 11, 2024
- Report Date
- March 6, 2025
- Manufacturer
- MICROPORT ORTHOPEDICS INC.
- Product Code
- MBH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THIS EVENT HAS BEEN REPORTED UNDER INCIDENT 24100027. PLEASE VOID THIS REPORT.
Additional Manufacturer Narrative · 0
THIS EVENT WILL BE UPDATED ONCE THE INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.
Description of Event or Problem · 0
ALLEGEDLY, MICROPORT ORTHOPEDICS INC. RECEIVED FEEDBACK ON FEMUR CONDYLAR EFSRP5PR LOT NO. 2007116. WHEN THE PRODUCT WAS OPENED IT WAS FOUND THAT THE ACTUAL PRODUCT WAS FEMUR CONDYLAR EFSRN6PL LOT NO. MP2002559, MANUFACTURED BY MICROPORT ORTHOPEDICS INC. CONFIRM THAT THERE IS A RISK OF MIXING THE TWO BATCHES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2510917 | EVOLUTION®MP FEM CS/CR POROUS | NO MATCH | MBH | MICROPORT ORTHOPEDICS INC. | EFSRP5PR | 2007116 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |