FDA Adverse Event
Injury
Summary report: N
LINEAGE TRANSCEND CERAMIC ACETABULAR LINER
MDR report key: 1001021
·
Received February 20, 2008
Report
- Report Number
- 1043534-2008-00021
- Event Type
- Injury
- Date Received
- February 20, 2008
- Date of Event
- February 14, 2008
- Report Date
- February 14, 2008
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- MRA
- PMA / PMN Number
- P030027
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. ADDITIONAL INFO HAS BEEN REQUESTED. THIS REPORT WILL BE AMENDED WHEN THE INVESTIGATION IS COMPLETED. THIS IS THE SAME EVENT AS 1043534-2008-00020. THIS EVENT OCCURRED IN ANOTHER COUNTRY.
Description of Event or Problem · 1
ALLEGEDLY, SURGEON'S NOTES INDICATE THAT THE PT HEARD SQUEAKING SOUND DAY ONE OF WEIGHT BEARING/WALKING. REVISED DUE TO FRACTURE OF CERAMIC HEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LINEAGE TRANSCEND CERAMIC ACETABULAR LINER | MRA | WRIGHT MEDICAL TECHNOLOGY, INC. | 07492592 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Unknown | Hospitalization| R |