FDA Adverse Event
Injury
Summary report: N
ITOTAL G2
MDR report key: 4845034
·
Received June 10, 2015
Report
- Report Number
- 3004153240-2015-00109
- Event Type
- Injury
- Date Received
- June 10, 2015
- Date of Event
- April 22, 2015
- Report Date
- May 13, 2015
- Manufacturer
- CONFORMIS, INC.
- Product Code
- JWH
- PMA / PMN Number
- K120316
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
REVISION SURGERY OCCURRED FOR PATIENT WITH A TOTAL KNEE IMPLANT. REASON FOR REVISION IS UNKNOWN. REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE DEVICE IS MANUFACTURED TO SPECIFICATION.
Description of Event or Problem · 1
REVISION SURGERY OCCURRED FOR PATIENT WITH A TOTAL KNEE IMPLANT. REASON FOR REVISION IS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 373599 | ITOTAL G2 | TOTAL KNEE REPLACEMENT SYSTEM | JWH | CONFORMIS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Required Intervention |