FDA Adverse Event
Injury
Summary report: N
NEXGEN PRECOAT TIBIAL PLATE
MDR report key: 4240396
·
Received October 30, 2014
Report
- Report Number
- 2648920-2014-00293
- Event Type
- Injury
- Date Received
- October 30, 2014
- Date of Event
- February 22, 2011
- Report Date
- December 12, 2013
- Manufacturer
- ZIMMER
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE. THE INFORMATION PROVIDED ON THIS FORM WAS PREVIOUSLY SUBMITTED UNDER MANUFACTURING REPORT NUMBER 1822565-2014-00004.
Description of Event or Problem · 1
IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIAL COMPONENT AND FRACTURE OF THE TIBIAL PLATEAU.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 695239 | NEXGEN PRECOAT TIBIAL PLATE | JWH | ZIMMER | 61615325 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Required Intervention | PALACOS R+G BONE CEMENT: CAT #00111314001,| LOT #70354234 |