FDA Adverse Event
Injury
Summary report: N
LINEAGE(R) TRANSCEND(R) CERAMIC ACETABULAR LINER
MDR report key: 2220938
·
Received August 23, 2011
Report
- Report Number
- 1043534-2011-00477
- Event Type
- Injury
- Date Received
- August 23, 2011
- Date of Event
- July 19, 2011
- Report Date
- August 19, 2011
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- LZO
- PMA / PMN Number
- K893685
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED THE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. ALTHOUGH ATTEMPTS HAVE BEEN MADE, NO MEDWATCH 3500A HAS BEEN RECEIVED FROM THE USER FACILITY. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2011-00478, 00479.
Additional Manufacturer Narrative · 1
CONCLUSION: NO CONCLUSION CAN BE DRAWN. THE COMPLAINT WAS REVIEWED AND ANALYSIS SHOWED NO TREND. THE PACKAGE INSERT WAS ALSO REVIEWED. THE PRODUCT WAS NOT RETURNED. EVIDENCE THAT PRODUCT IN SPECIFICATION WHEN USED.
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 | LZO | WRIGHT MEDICAL TECHNOLOGY, INC. | 094117146 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |