FDA Adverse Event
Injury
Summary report: N
NEXGEN LPS-MOBILE MIS TIBIAL COMPONENT
MDR report key: 2023528
·
Received March 16, 2011
Report
- Report Number
- 1822565-2011-00643
- Event Type
- Injury
- Date Received
- March 16, 2011
- Date of Event
- February 14, 2011
- Report Date
- February 17, 2011
- Manufacturer
- ZIMMER, INC.
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
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 PT WAS REVISED DUE TO LOOSENING OF THE TIBIAL COMPONENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEXGEN LPS-MOBILE MIS TIBIAL COMPONENT | JWH | ZIMMER, INC. | 61265399 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |