FDA Adverse Event
Injury
Summary report: N
IUNI G2
MDR report key: 3170080
·
Received June 5, 2013
Report
- Report Number
- 3004153240-2013-00097
- Event Type
- Injury
- Date Received
- June 5, 2013
- Date of Event
- May 1, 2013
- Report Date
- May 20, 2013
- Manufacturer
- CONFORMIS
- Product Code
- HSX
- PMA / PMN Number
- K111916
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PATIENT WITH A UNICONDYLAR KNEE IMPLANT DEVELOPED AN INFECTION. REVISION SURGERY IS PLANNED. REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. ALL STERILIZATION REQUIREMENTS WERE MET.
Description of Event or Problem · 1
PT WITH A UNICONDYLAR KNEE IMPLANT DEVELOPED AN INFECTION. REVISION SURGERY IS PLANNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 249471 | IUNI G2 | UNICONDYLAR KNEE REPLACEMENT SYSTEM | HSX | CONFORMIS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Required Intervention |