FDA Adverse Event
Injury
Summary report: N
CO-CR
MDR report key: 1140957
·
Received August 28, 2008
Report
- Report Number
- 1020279-2008-00236
- Event Type
- Injury
- Date Received
- August 28, 2008
- Date of Event
- July 21, 2008
- Report Date
- August 28, 2008
- Manufacturer
- SMITH & NEPHEW, INC., ORTHOPAEDIC DIV
- Product Code
- KWY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NA
Description of Event or Problem · 1
IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CO-CR | FEMORAL HEAD | KWY | SMITH & NEPHEW, INC., ORTHOPAEDIC DIV | NA | 00510367A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Hospitalization| O |