FDA Adverse Event
Injury
Summary report: N
GII STANDARD TIBIA B
MDR report key: 2991074
·
Received March 6, 2013
Report
- Report Number
- 8010764-2013-00014
- Event Type
- Injury
- Date Received
- March 6, 2013
- Date of Event
- January 17, 2013
- Report Date
- February 20, 2013
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT ON (B)(6) 2013 THE PATIENT HAD FLUID REMOVED FROM HIS KNEE. ON (B)(6) 2013 THE PATIENT RECEIVED ORTHOSCOPIC SURGERY TO REMOVE SCAR TISSUE, BONE FRAGMENTS AND BONE SPURS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 95875 | GII STANDARD TIBIA B | GNS II CMT TIB SIZE 6 {} LEFT | JWH | SMITH & NEPHEW, INC. | 08DT18841 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Required Intervention | (B)(4)| (B)(4)| (B)(4) |