FDA Adverse Event
Injury
Summary report: N
DYNASTY(R) COCR LINER
MDR report key: 8317777
·
Received February 7, 2019
Report
- Report Number
- 3010536692-2019-00359
- Event Type
- Injury
- Date Received
- February 7, 2019
- Report Date
- February 7, 2019
- Manufacturer
- MICROPORT ORTHOPEDICS INC.
- Product Code
- JDL
- 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 FROM 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 |
|---|---|---|---|---|---|---|---|
| 108863 | DYNASTY(R) COCR LINER | HIP COMPONENT | JDL | MICROPORT ORTHOPEDICS INC. | DLCO-GF42 | 109966091 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |