FDA Adverse Event
Other
Summary report: N
FMP ACETABULAR SYSTEM
MDR report key: 355028
·
Received October 8, 2001
Report
- Report Number
- 1644408-2001-00020
- Event Type
- Other
- Date Received
- October 8, 2001
- Date of Event
- August 1, 2001
- Report Date
- September 14, 2001
- Manufacturer
- ENCORE ORTHOPEDICS, INC.
- Product Code
- LPH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ACETABULAR LINER REVISED DUE TO DISLOCATION CAUSED BY IMPLANTATION ERROR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 45243 | FMP ACETABULAR SYSTEM | ACETABULAR LINER | LPH | ENCORE ORTHOPEDICS, INC. | * | 514491 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |