FDA Adverse Event
Injury
Summary report: N
RESTORIS ACETABULAR LINER
MDR report key: 3084901
·
Received April 26, 2013
Report
- Report Number
- 3009701876-2013-00006
- Event Type
- Injury
- Date Received
- April 26, 2013
- Date of Event
- March 27, 2013
- Report Date
- April 26, 2013
- Manufacturer
- PIPELINE ORTHOPEDICS LLC
- Product Code
- OQH
- PMA / PMN Number
- K112802
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
AS PART OF AN INCISION AND DRAINAGE REVISION PROCEDURE, THE SURGEON REPLACED THE ACETABULAR LINER AND FEMORAL HEAD COMPONENTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 182841 | RESTORIS ACETABULAR LINER | OQH | PIPELINE ORTHOPEDICS LLC | 186136-54 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Required Intervention |