FDA Adverse Event
Injury
Summary report: N
NEXGEN MIS STEMMED TIBIAL COMPONENT
MDR report key: 2922233
·
Received January 11, 2013
Report
- Report Number
- 1822565-2013-00084
- Event Type
- Injury
- Date Received
- January 11, 2013
- Date of Event
- August 29, 2007
- Report Date
- May 29, 2012
- Manufacturer
- ZIMMER INC
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFORMATION 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 WAS REVISED DUE TO FILED RANGE OF MOTION PROGRESS. IT IS ALSO REPORTED THAT THE PT UNDERWENT MULTIPLE MANIPULATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 16757 | NEXGEN MIS STEMMED TIBIAL COMPONENT | JWH | ZIMMER INC | 60372792 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Required Intervention | UNK ZIMMER FEMORAL COMPONENT,CATALOG #UNK, LOT#UNK| UNK ZIMMER PATELLA, CATALOG#UNK, LOT #UNK| UNK ZIMME RARTICULAR SURFACE, CATALOG#UNK, LOT#UNK |