FDA Adverse Event
Other
Summary report: N
FOUNDATION HIP SYSTEM
MDR report key: 1031767
·
Received April 18, 2008
Report
- Report Number
- 1644408-2008-00121
- Event Type
- Other
- Date Received
- April 18, 2008
- Date of Event
- March 26, 2008
- Report Date
- April 17, 2008
- Manufacturer
- ENCORE MEDICAL, L.P.
- Product Code
- KWY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
REVISION SURGERY - FRACTURED FEMUR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FOUNDATION HIP SYSTEM | HIP STEM, HA COATED | KWY | ENCORE MEDICAL, L.P. | 53862094 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention | 411-00-350/53910273| 497-38-000/53806845 |