FDA Adverse Event
Injury
Summary report: N
CONSERVE(R) TOTAL A-CLASS HEAD
MDR report key: 7996866
·
Received October 23, 2018
Report
- Report Number
- 3010536692-2018-01359
- Event Type
- Injury
- Date Received
- October 23, 2018
- Report Date
- October 23, 2018
- Manufacturer
- MICROPORT ORTHOPEDICS INC.
- Product Code
- JDL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ALLEGEDLY, PATIENT SUFFERING FROM DEFECTIVE HIP. ADDITIONAL INFORMATION RECEIVED 09/24/2018. PATIENT HAS NOW BEEN REVISED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 838540 | CONSERVE(R) TOTAL A-CLASS HEAD | HIP COMPONENT | JDL | MICROPORT ORTHOPEDICS INC. | 38AM-4204 | 018533958 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |