FDA Adverse Event
Injury
Summary report: N
TM ARDIS
MDR report key: 4196891
·
Received October 15, 2014
Report
- Report Number
- 3005751028-2014-00080
- Event Type
- Injury
- Date Received
- October 15, 2014
- Report Date
- October 15, 2014
- Manufacturer
- ZIMMER TRABECULAR METAL TECHNOLOGY
- Product Code
- KWP
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS IN PROGRESS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE TM ARDIS CAGE POST SURGERY HAD MIGRATED. IT WAS ALSO NOTED FOR THIS CASE, THAT THE PT MAY HAVE BEEN REVISED DUE TO IRRITATION, HOWEVER, IT WAS NOT CONFIRMED AS YET.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 655256 | TM ARDIS | TM ARDIS | KWP | ZIMMER TRABECULAR METAL TECHNOLOGY | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |