FDA Adverse Event
Injury
Summary report: N
LINEAGE(R) TRANSCEND(R) SUPERFINISHED FEMORAL HEAD
MDR report key: 3802428
·
Received May 9, 2014
Report
- Report Number
- 3010536692-2014-00773
- Event Type
- Injury
- Date Received
- May 9, 2014
- Date of Event
- January 14, 2014
- Report Date
- April 11, 2014
- Manufacturer
- MICROPORT ORTHOPEDICS INC.
- Product Code
- JDL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED IN (B)(6). THIS IS THE SAME EVENT AS 3010536692-2014-00771, 00772, 00774.
Description of Event or Problem · 1
ALLEGEDLY THE PATIENT WAS REVISED DUE TO PAIN (LEFT). (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 281461 | LINEAGE(R) TRANSCEND(R) SUPERFINISHED FEMORAL HEAD | HIP COMPONENT | JDL | MICROPORT ORTHOPEDICS INC. | 07492049 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |