FDA Adverse Event
Other
Summary report: N
FOUNDATION HIP SYSTEM
MDR report key: 1023514
·
Received March 28, 2008
Report
- Report Number
- 1644408-2008-00115
- Event Type
- Other
- Date Received
- March 28, 2008
- Date of Event
- March 1, 2008
- Report Date
- March 28, 2008
- Manufacturer
- ENCORE MEDICAL, L.P.
- Product Code
- KWB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
REVISION SURGERY - PT HAD AN INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FOUNDATION HIP SYSTEM | BIPOLAR SHELL | KWB | ENCORE MEDICAL, L.P. | 53867165 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Required Intervention |