FDA Adverse Event
Injury
Summary report: N
CONSERVE(R) TOTAL A-CLASS HEAD
MDR report key: 8317776
·
Received February 7, 2019
Report
- Report Number
- 3010536692-2019-00360
- Event Type
- Injury
- Date Received
- February 7, 2019
- Report Date
- February 7, 2019
- Manufacturer
- MICROPORT ORTHOPEDICS INC.
- Product Code
- JDL
- PMA / PMN Number
- K051348
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ALLEGEDLY THE PATIENT IS EXPERIENCING MOM COMPLICATIONS (LEFT). ADDITIONAL INFORMATION RECEIVED FORM LITIGATION ON 01/108/2019. ALLEGEDLY THE PATIENT WAS REVISED DUE TO MOM COMPLICATIONS. ADDED THE EXPLANT DATE (LEFT).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 108861 | CONSERVE(R) TOTAL A-CLASS HEAD | HIP COMPONENT | JDL | MICROPORT ORTHOPEDICS INC. | 38AM-4235 | 029805761 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |