FDA Adverse Event
Injury
Summary report: N
LINEAGE(R) TRANSCEND(R) SUPERFINISHED FEMORAL HEAD
MDR report key: 5999874
·
Received October 5, 2016
Report
- Report Number
- 3010536692-2016-01244
- Event Type
- Injury
- Date Received
- October 5, 2016
- Report Date
- September 20, 2016
- Manufacturer
- MICROPORT ORTHOPEDICS INC.
- Product Code
- JDL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT WILL BE UPDATED WHEN INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.
Description of Event or Problem · 1
ALLEGEDLY THE PATIENT HAD HIP REPLACEMENT SURGERY ON (B)(6) 2016. REVISED DYNASTY A-CLASS LINER AND LINEAGE TRANSCEND FEMORAL HEAD, LONG, DUE TO DISLOCATION AND OFFSET REQUIRED ON (B)(6) 2016. REPLACED WITH DYNASTY A-CLASS LINER AND LINEAGE TRANSCEND FEMORAL HEAD, X-LONG.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 652906 | LINEAGE(R) TRANSCEND(R) SUPERFINISHED FEMORAL HEAD | HIP COMPONENT | JDL | MICROPORT ORTHOPEDICS INC. | 15972051607035 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |