FDA Adverse Event
Malfunction
Summary report: N
NKII NONPOROUS REVISION FEMORAL COMPONENT
MDR report key: 1950106
·
Received December 7, 2010
Report
- Report Number
- 1822565-2010-01296
- Event Type
- Malfunction
- Date Received
- December 7, 2010
- Report Date
- November 24, 2010
- Manufacturer
- ZIMMER, INC.
- Product Code
- JWH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- 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 THE PT IS PRESENTING WITH PAIN AND SWELLING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NKII NONPOROUS REVISION FEMORAL COMPONENT | KNEE PROSTHESIS | JWH | ZIMMER, INC. | 60830871 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | CATALOG #620508111, LOT #60350994| CATALOG #621512125, LOT #1575161| NATURAL KNEE II NONPOROUS REVISION FEMORAL SPACER| NATURAL KNEE II NONPOROUS REVISION FEMORAL SPACER| CATALOG #620508110, LOT #60907748| NATURAL KNEE II REVISION STEM| UNK NATURAL KNEE II ULTRACONGRUENT TIBIAL INSERT| CATALOG #UNK, LOT #UNK |