FDA Adverse Event
Injury
Summary report: N
NEXGEN LPS-MOBILE ARTICULAR SURFACE
MDR report key: 1841542
·
Received September 14, 2010
Report
- Report Number
- 1822565-2010-00677
- Event Type
- Injury
- Date Received
- September 14, 2010
- Date of Event
- May 26, 2010
- Report Date
- August 18, 2010
- Manufacturer
- ZIMMER, INC.
- Product Code
- LXH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, 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 PATIENT HAD TO BE REVISED DUE TO THE FRACTURE OF THE ARTICULAR SURFACE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEXGEN LPS-MOBILE ARTICULAR SURFACE | KNEE INSTRUMENT | LXH | ZIMMER, INC. | 60130847 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Required Intervention |