FDA Adverse Event
Other
Summary report: N
FOUNDATION HIP SYSTEM
MDR report key: 918294
·
Received September 21, 2007
Report
- Report Number
- 1644408-2007-00186
- Event Type
- Other
- Date Received
- September 21, 2007
- Date of Event
- September 6, 2007
- Report Date
- September 21, 2007
- Manufacturer
- ENCORE MEDICAL, L.P.
- Product Code
- KWY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
PT FELL AND FRACTURED FEMURE AROUND STEM. STEM REMOVED AND REPLACED WITH CEMENTED STEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FOUNDATION HIP SYSTEM | HIP STEM | KWY | ENCORE MEDICAL, L.P. | 959181 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 93 YR | Required Intervention |