FDA Adverse Event
Injury
Summary report: N
LINEAGE(R) TRANSCEND(R) CERAMIC ACETABULAR LINER
MDR report key: 1980799
·
Received February 7, 2011
Report
- Report Number
- 1043534-2011-00053
- Event Type
- Injury
- Date Received
- February 7, 2011
- Date of Event
- December 14, 2010
- Report Date
- January 14, 2011
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- MRA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCLUSION: NO CONCLUSION CAN BE DRAWN.COMPLAINT REVIEWED AND ANALYSIS SHOWED NO TREND FOR (B)(4), LOT NO: 027408629. DEVICE HISTORY RECORD REVIEWED. PRODUCT NOT RETURNED.
Additional Manufacturer Narrative · 1
INVESTIGATION IS NOT COMPLETE. THE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. THIS IS THE SAME EVENT AS 1043534-2011-00054, 00055. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS EVENT OCCURRED IN (B)(6).
Description of Event or Problem · 1
ALLEGEDLY REVISED DUE TO A BROKEN LINER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LINEAGE(R) TRANSCEND(R) CERAMIC ACETABULAR LINER | HIP COMPONENT | MRA | WRIGHT MEDICAL TECHNOLOGY, INC. | 027408629 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR | Hospitalization| R |