FDA Adverse Event
Injury
Summary report: N
CONSERVE(R) TOTAL A-CLASS HEAD
MDR report key: 5063162
·
Received September 8, 2015
Report
- Report Number
- 3010536692-2015-01671
- Event Type
- Injury
- Date Received
- September 8, 2015
- Date of Event
- June 4, 2013
- Report Date
- September 8, 2015
- Manufacturer
- MICROPORT ORTHOPEDICS INC.
- Product Code
- JDL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS IS THE SAME EVENT AS 3010536692-2015-01670.
Description of Event or Problem · 1
ALLEGEDLY, PATIENT WAS REVISED DUE TO MOM COMPLICATIONS: PAIN; DIFFICULTY AMBULATION. RIGHT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 594242 | CONSERVE(R) TOTAL A-CLASS HEAD | HIP COMPONENT | JDL | MICROPORT ORTHOPEDICS INC. | 106382899 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Required Intervention |