FDA Adverse Event
Malfunction
Summary report: N
NEXGEN MIS TOTAL STEMMED TIBIAL COMPONENT
MDR report key: 1934170
·
Received December 8, 2010
Report
- Report Number
- 1822565-2010-01310
- Event Type
- Malfunction
- Date Received
- December 8, 2010
- Report Date
- November 11, 2010
- Manufacturer
- ZIMMER INC
- Product Code
- JWH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- UNKNOWN
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 PT IS PRESENTING WITH PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEXGEN MIS TOTAL STEMMED TIBIAL COMPONENT | KNEE PROSTHESIS | JWH | ZIMMER INC | 61198692 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | CATALOG #00595001702, LOT #61130615| CRUCIATE RETAINING ARTICULAR SURFACE| ALL POLY PATELLA| CATALOG #00595204010, LOT #61302944| PROLONG HIGHLY CROSSLINKED POLYETHYLENE NEXGEN| NEXGEN CRUCIATE RETAINING CR-FLEX| NEXGEN PROLONG HIGHLY CROSSLINKED POLYETHYLENE| CATALOG #00597206635, LOT #61183351 |