FDA Adverse Event
Other
Summary report: N
FEMORAL HEAD COMPONENTS
MDR report key: 1172656
·
Received September 15, 2008
Report
- Report Number
- 1644408-2008-00318
- Event Type
- Other
- Date Received
- September 15, 2008
- Date of Event
- August 27, 2008
- Report Date
- August 28, 2008
- Manufacturer
- ENCORE MEDICAL, L.P.
- Product Code
- KWY
- PMA / PMN Number
- K973302
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
REVISION SURGERY - REPEATED DISLOCATIONS. THE PT WAS NON-COMPLIANT IN DAILY ACTIVITIES AND RECENTLY WAS REVISED TO A COSTRAINED LINER BY A DIFFERENT SURGEON.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FEMORAL HEAD COMPONENTS | HEAD, M-M FEM. 28/3.5MM | KWY | ENCORE MEDICAL, L.P. | 53797683 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 88 YR | Required Intervention | 433-28-205 |