FDA Adverse Event
Injury
Summary report: N
GENDER SOLUTIONS NK FLEX FEMORAL COMPONENT
MDR report key: 2925020
·
Received January 17, 2013
Report
- Report Number
- 1822565-2013-00119
- Event Type
- Injury
- Date Received
- January 17, 2013
- Date of Event
- October 13, 2011
- Report Date
- December 18, 2012
- Manufacturer
- ZIMMER, INC.
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
INFO WAS RECEIVED FROM A FOREIGN SOURCE 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 UNDERWENT AN ARTHROSCOPIC PROCEDURE DUE TO PAIN AND EFFUSION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 26556 | GENDER SOLUTIONS NK FLEX FEMORAL COMPONENT | JWH | ZIMMER, INC. | 61078156 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Required Intervention | CATALOG #630802301, LOT #00111679| NK II ROTATING PLATFORM TIBIAL BASEPLATE| GENDER SOLUTIONS NATURAL-KNEE FLEX ROTATING| CATALOG #00543201311, LOT #61037952| PLATFORM ARTICULAR SURFACE |