FDA Adverse Event
Injury
Summary report: N
IUNI G2
MDR report key: 2973488
·
Received February 14, 2013
Report
- Report Number
- 3004153240-2013-00020
- Event Type
- Injury
- Date Received
- February 14, 2013
- Date of Event
- January 1, 2013
- Report Date
- January 21, 2013
- Manufacturer
- CONFORMIS
- Product Code
- HSX
- PMA / PMN Number
- K092441
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION.
Description of Event or Problem · 1
REVISION SURGERY PLANNED FOR PT WITH A UNICONDYLAR KNEE IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 66192 | IUNI G2 | UNICINDYLAR KNEE REPLACEMENT SYSTEM | HSX | CONFORMIS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Required Intervention |