FDA Adverse Event
Injury
Summary report: N
IUNI G2
MDR report key: 2082731
·
Received April 28, 2011
Report
- Report Number
- 3004153240-2011-00021
- Event Type
- Injury
- Date Received
- April 28, 2011
- Date of Event
- March 1, 2011
- Report Date
- March 28, 2011
- Manufacturer
- CONFORMIS
- Product Code
- HSX
- PMA / PMN Number
- K092441
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PT WITH A UNICONDYLAR KNEE IMPLANT DEVELOPED AN INFECTION. REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT ALL PROCESS STEPS WERE DOCUMENTED AND COMPLETED SUCCESSFULLY AND ALL STERILIZATION REQUIREMENTS WERE MET.
Description of Event or Problem · 1
PT WITH A UNICONDYLAR KNEE IMPLANT DEVELOPED AN INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IUNI G2 | UNICONDYLAR KNEE REPAIR SYSTEM | HSX | CONFORMIS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Hospitalization |