FDA Adverse Event
Injury
Summary report: N
CONSERVE® TOTAL A-CLASS® HEAD
MDR report key: 7527290
·
Received May 18, 2018
Report
- Report Number
- 3010536692-2018-00660
- Event Type
- Injury
- Date Received
- May 18, 2018
- Report Date
- May 18, 2018
- 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 WAS EXPERIENCING UNKNOWN MOM COMPLICATIONS. ADDITIONAL INFORMATION RECEIVED FROM LITIGATIONS ON 05/09/2018. ALLEGEDLY THE PATIENT WAS REVISED DUE TO MOM COMPLICATIONS. (LEFT).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 368799 | CONSERVE® TOTAL A-CLASS® HEAD | HIP COMPONENT | JDL | MICROPORT ORTHOPEDICS INC. | 38AM-4804 | 098700926 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |