FDA Adverse Event
Other
Summary report: N
ENCORE MODULAR HIP SYSTEM
MDR report key: 1061738
·
Received June 16, 2008
Report
- Report Number
- 1644408-2008-00185
- Event Type
- Other
- Date Received
- June 16, 2008
- Date of Event
- May 21, 2008
- Report Date
- May 22, 2008
- Manufacturer
- ENCORE MEDICAL, L.P.
- Product Code
- KWB
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
REVISION SURGERY-REPEATED DISLOCATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENCORE MODULAR HIP SYSTEM | BIPOLAR SHELL | KWB | ENCORE MEDICAL, L.P. | 53882001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 88 YR | Required Intervention | 497-28-000 |