FDA Adverse Event
Injury
Summary report: N
1020279-2012-00664
MDR report key: 2861387
·
Received December 7, 2012
Report
- Report Number
- 1020279-2012-00664
- Event Type
- Injury
- Date Received
- December 7, 2012
- Date of Event
- March 22, 2012
- Report Date
- November 30, 2012
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A REVISION WAS PERFORMED DUE TO INFECTION: (B)(6) 2011 - LOW GRADE FEVER, KNEE BEGAN TO DRAIN HEMATOMA. (B)(6) 2011 - EMERGENCY SURGERY ( IRRIGATION AND DEBRIDEMENT). (B)(6) 2011 - TESTED (B)(6) FOR (B)(6) INFECTION, NEXT COUPLE OF WEEKS THE PATIENT HAD NUMEROUS OF SURGERIES WHILE QUARANTINE IN THE HOSPITAL. (B)(6) 2011 - SURGERY (IRRIGATION AND DEBRIDEMENT, REMOVED THE ALLOGRAFT AND INFECTED PARTS AND INSERTED AN ANTIBIOTIC SPACER). (B)(6), 2012 - REVISION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | JWH | SMITH & NEPHEW, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |