FDA Adverse Event
Injury
Summary report: N
PERSONA PEGGED POROUS TIBIAL PLATE
MDR report key: 4252913
·
Received November 12, 2014
Report
- Report Number
- 1822565-2014-01576
- Event Type
- Injury
- Date Received
- November 12, 2014
- Report Date
- October 14, 2014
- Manufacturer
- ZIMMER, INC.
- Product Code
- OIY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, 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 IS REPORTED THAT THE SURGEON HAS OBSERVED RADIOLUCENCY ON ONE POST OP X-RAYS FOR THIS PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 728986 | PERSONA PEGGED POROUS TIBIAL PLATE | OIY | ZIMMER, INC. | 62331234 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |