FDA Adverse Event
Injury
Summary report: N
NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-POSTERIOR STABILIZED LPS-FLEX ARTICULA
MDR report key: 1242229
·
Received November 19, 2008
Report
- Report Number
- 1822565-2008-00814
- Event Type
- Injury
- Date Received
- November 19, 2008
- Date of Event
- October 11, 2008
- Report Date
- October 15, 2008
- Manufacturer
- ZIMMER, INC.
- Product Code
- HSA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
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 DEVICE WAS IMPLANTED IN 2008 AND WAS EXPLANTED IN 2008, DUE TO DRAINAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-POSTERIOR STABILIZED LPS-FLEX ARTICULA | KNEE PROSTHESIS | HSA | ZIMMER, INC. | NA | 61033164 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Hospitalization| R |