FDA Adverse Event
Injury
Summary report: N
GENDER SOLUTIONS NATURAL KNEE ART SURFACE
MDR report key: 2082918
·
Received May 3, 2011
Report
- Report Number
- 1822565-2011-01095
- Event Type
- Injury
- Date Received
- May 3, 2011
- Report Date
- April 5, 2011
- Manufacturer
- ZIMMER INC
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT IS REPORTED THAT THE PATIENT IS EXPERIENCING PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GENDER SOLUTIONS NATURAL KNEE ART SURFACE | MNH | JWH | ZIMMER INC | 60964471 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM GENDER| LOT # 61103144| SOLUTIONS FEMORAL COMPONENT, CATALOG #00541201702| GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM PATELLA| NATURAL-KNEE SYSTEM STEMMED TIBIAL BASEPLATE:| CATALOG # 621201230, LOT # 61168765| COMPONENT: CATALOG #00541800001, LOT # 61086329 |