FDA Adverse Event
Injury
Summary report: N
IUNI G2
MDR report key: 3030625
·
Received March 25, 2013
Report
- Report Number
- 3004153240-2013-00052
- Event Type
- Injury
- Date Received
- March 25, 2013
- Manufacturer
- CONFORMIS
- Product Code
- HSX
- PMA / PMN Number
- K111916
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
REVISION SURGERY OCCURRED FOR PATIENT WITH A UNICONDYLAR KNEE IMPLANT. PATIENT WAS REVISED TO A TKA. REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS.
Description of Event or Problem · 1
REVISION SURGERY OCCURRED FOR PATIENT WITH A UNICONDYLAR KNEE IMPLANT. PATIENT WAS REVISED TO A TKA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 121350 | IUNI G2 | UNICONDYLAR KNEE REPAIR SYSTEM | HSX | CONFORMIS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |