FDA Adverse Event
Injury
Summary report: N
COCR
MDR report key: 2192049
·
Received August 4, 2011
Report
- Report Number
- 1020279-2011-00300
- Event Type
- Injury
- Date Received
- August 4, 2011
- Date of Event
- June 10, 2011
- Report Date
- July 22, 2011
- Manufacturer
- SMITH AND NEPHEW, INC
- Product Code
- MBL
- 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 SURGERY WAS PERFORMED DUE TO INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COCR | FEMORAL HEAD COMPONENT | MBL | SMITH AND NEPHEW, INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |