FDA Adverse Event
Injury
Summary report: N
UNKNOWN
MDR report key: 2133455
·
Received June 20, 2011
Report
- Report Number
- 1020279-2011-00204
- Event Type
- Injury
- Date Received
- June 20, 2011
- Report Date
- June 20, 2011
- Manufacturer
- SMTIH & NEPHEW, INC. ORTHOPAEDIC DIVISION
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT HAS BEEN REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION. THE PRIMARY SURGERY WAS ABOUT 5 YEARS AGO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN | INSERT | JWH | SMTIH & NEPHEW, INC. ORTHOPAEDIC DIVISION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |