FDA Adverse Event
Injury
Summary report: N
CONSERVE(R) PLUS CUP
MDR report key: 6216014
·
Received December 30, 2016
Report
- Report Number
- 3010536692-2016-01563
- Event Type
- Injury
- Date Received
- December 30, 2016
- Report Date
- December 21, 2016
- Manufacturer
- MICROPORT ORTHOPEDICS INC.
- Product Code
- KWA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ALLEGEDLY THE PATIENT HAD PAIN AND HIGH COBALT LEVELS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 865653 | CONSERVE(R) PLUS CUP | HIP COMPONENT | KWA | MICROPORT ORTHOPEDICS INC. | 045202460 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |