FDA Adverse Event
Injury
Summary report: N
LINEAGE(R) TRANSCEND(R) CERAMIC FEMORAL HEAD
MDR report key: 3122979
·
Received May 21, 2013
Report
- Report Number
- 1043534-2013-00835
- Event Type
- Injury
- Date Received
- May 21, 2013
- Report Date
- May 21, 2013
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- MRA
- PMA / PMN Number
- P030027
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCLUSION: NO CONCLUSION CAN BE DRAWN. THE COMPLAINT WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT. THE PRODUCT WAS NOT RETURNED.(B)(4).
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 IS THE SAME EVENT AS 1043534-2013-00649, 00834.
Description of Event or Problem · 1
ALLEGEDLY PER SURGEON, I HAVE A PATIENT WITH COBALT CHROME MODULAR NECK AND CERAMIC ON CERAMIC ARTICULATION WHO IS NOW FACING REVISION SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 225121 | LINEAGE(R) TRANSCEND(R) CERAMIC FEMORAL HEAD | HIP COMPONENT, CODE:MRA | MRA | WRIGHT MEDICAL TECHNOLOGY, INC. | 1101232345 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |