FDA Adverse Event
Injury
Summary report: N
PERSONA NATURAL TIBIA
MDR report key: 3093670
·
Received May 1, 2013
Report
- Report Number
- 1822565-2013-00732
- Event Type
- Injury
- Date Received
- May 1, 2013
- Report Date
- April 1, 2013
- Manufacturer
- ZIMMER INC
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THAT 4-WEEK POST-OPERATIVE XRAYS SHOW RADIOLUCENCY ABOUT THE POSTERIOR ASPECT OF THE TIBIAL IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 188946 | PERSONA NATURAL TIBIA | JWH | ZIMMER INC | 62252648 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |