FDA Adverse Event
Injury
Summary report: N
NATURAL KNEE FLEX PROLONG ARTICULAR SURFACE
MDR report key: 1971591
·
Received January 25, 2011
Report
- Report Number
- 1822565-2011-00119
- Event Type
- Injury
- Date Received
- January 25, 2011
- Date of Event
- December 26, 2010
- Report Date
- December 29, 2010
- 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 THE TIBIAL INSERT DISLODGING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NATURAL KNEE FLEX PROLONG ARTICULAR SURFACE | KNEE PROSTHESIS | JWH | ZIMMER, INC. | 60874728 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Required Intervention |