FDA Adverse Event
Injury
Summary report: N
LINEAGE(R) TRANSCEND(R) SUPERFINISHED FEMORAL HEAD
MDR report key: 2991747
·
Received March 6, 2013
Report
- Report Number
- 1043534-2013-00490
- Event Type
- Injury
- Date Received
- March 6, 2013
- Date of Event
- November 4, 2011
- Report Date
- October 22, 2012
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- JDL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS EVENT OCCURRED IN (B)(6).
Additional Manufacturer Narrative · 1
CONCLUSION: NO DEVICE FAILURE. THE COMPLAINT WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT. THE PRODUCT WAS NOT RETURNED.EVIDENCE THAT PRODUCT IN SPECIFICATION WHEN USED. (B)(4).
Description of Event or Problem · 1
ALLEGEDLY REVISED DUE TO INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 94932 | LINEAGE(R) TRANSCEND(R) SUPERFINISHED FEMORAL HEAD | HIP COMPONENT, CODE:JDL | JDL | WRIGHT MEDICAL TECHNOLOGY, INC. | 119973178 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Required Intervention |