FDA Adverse Event
Injury
Summary report: N
NEXGEN STEMMED TIBIAL PLATE
MDR report key: 2120044
·
Received June 7, 2011
Report
- Report Number
- 1822565-2011-01320
- Event Type
- Injury
- Date Received
- June 7, 2011
- Date of Event
- May 10, 2011
- Report Date
- May 11, 2011
- Manufacturer
- ZIMMER INC.
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFO WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT IS REPORTED THAT THE PT WAS REVISED DUE TO PAIN, LOOSENING, AND THE TIBIAL PLATE FRACTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEXGEN STEMMED TIBIAL PLATE | JWH | ZIMMER INC. | 74774700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |