FDA Adverse Event
Injury
Summary report: N
NEXGEN STEMMED TIBIAL COMPONENT
MDR report key: 2212626
·
Received August 11, 2011
Report
- Report Number
- 1822565-2011-01811
- Event Type
- Injury
- Date Received
- August 11, 2011
- Date of Event
- April 12, 2011
- Report Date
- July 13, 2011
- 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
INFO 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 PT WAS REVISED DUE TO A LOOSE TIBIAL COMPONENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEXGEN STEMMED TIBIAL COMPONENT | JWH | ZIMMER, INC. | 60740913 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Required Intervention |