FDA Adverse Event
Malfunction
Summary report: N
NEXGEN STEMMED TIBIAL COMPONENT
MDR report key: 1934610
·
Received November 24, 2010
Report
- Report Number
- 1822565-2010-01202
- Event Type
- Malfunction
- Date Received
- November 24, 2010
- Date of Event
- June 20, 2010
- Manufacturer
- ZIMMER INC
- Product Code
- HSH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFO WAS RECEIVED FROM A CONSUMER 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'S KNEE CLICKS AND THAT REVISION IS PENDING FOR TIBIA LOOSENING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEXGEN STEMMED TIBIAL COMPONENT | KNEE PROSTHESIS | HSH | ZIMMER INC | 64463000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | CATALOG #00599601601, LOT #64259100| (B)(4)| KNEE-POSTERIOR STABILIZED (LPS) FEMORAL COMPONENT| CATALOG #00599605112, LOT #40875300| KNEE-POSTERIOR STABILIZED (LPS) ARTICULAR SURFACE| CATALOG #00597206529, LOT #63780700| (B)(4)| NEXGEN COMPLETE KNEE SOLUTION ALL POLY PATELLA |