FDA Adverse Event
Injury
Summary report: N
CONSERVE® HEAD
MDR report key: 7593856
·
Received June 12, 2018
Report
- Report Number
- 3010536692-2018-00791
- Event Type
- Injury
- Date Received
- June 12, 2018
- Report Date
- June 12, 2018
- Manufacturer
- MICROPORT ORTHOPEDICS INC.
- Product Code
- JDL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ALLEGEDLY, PER ARTICLE BY DOWDING AND BEAULE, ET AL., J ARTHROP. 2018: A PATIENT SUFFERED FAILURE BECAUSE OF ASEPTIC LOOSENING OF THE ACETABULAR COMPONENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 432991 | CONSERVE® HEAD | HIP IMPLANT | JDL | MICROPORT ORTHOPEDICS INC. | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |