FDA Adverse Event
Injury
Summary report: N
HEAD
MDR report key: 6370021
·
Received March 1, 2017
Report
- Report Number
- 3010536692-2017-00306
- Event Type
- Injury
- Date Received
- March 1, 2017
- Report Date
- February 2, 2017
- Manufacturer
- MICROPORT ORTHOPEDICS INC.
- Product Code
- JDL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ALLEGEDLY THE PATIENT WAS EXPERIENCING UNKNOWN MOM COMPLICATIONS. ADDITIONAL INFORMATION RECEIVED 02/02/2017. ALLEGEDLY THE PATIENT HAS BEEN UPDATED TO A RIGHT HIP CONSERVE SCHEDULED REVISION CLAIM AND IS SCHEDULED TO BE REVISED (B)(6) 2017. (RIGHT).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 153290 | HEAD | HIP COMPONENT | JDL | MICROPORT ORTHOPEDICS INC. | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |