FDA Adverse Event
Injury
Summary report: N
NEXGEN FLUTED STEMMED TIBIAL COMPONENT
MDR report key: 2082959
·
Received May 3, 2011
Report
- Report Number
- 1822565-2011-01083
- Event Type
- Injury
- Date Received
- May 3, 2011
- Date of Event
- October 15, 2009
- Report Date
- April 4, 2011
- Manufacturer
- ZIMMER, INC.
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT IS REPORTED THAT THE PATIENT WAS REVISED FOR LOOSENING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEXGEN FLUTED STEMMED TIBIAL COMPONENT | JWH | ZIMMER, INC. | 60605968 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |