FDA Adverse Event
Other
Summary report: N
FMP ACETABULAR SYSTEM
MDR report key: 370788
·
Received January 9, 2002
Report
- Report Number
- 1644408-2002-00001
- Event Type
- Other
- Date Received
- January 9, 2002
- Date of Event
- December 15, 2001
- Manufacturer
- ENCORE ORTHOPEDICS, INC.
- Product Code
- KWA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
TOTAL HIP REPLACEMENT SURGERY EXTENDED DUE TO FAILURE TO PROPERLY ASSEMBLE ACETABULAR LINER INTO SHELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FMP ACETABULAR SYSTEM | ACETABULAR LINER | KWA | ENCORE ORTHOPEDICS, INC. | * | 770291 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Other |