FDA Adverse Event
Injury
Summary report: N
NATURAL-KNEE II SYSTEM TIBIAL INSERT
MDR report key: 2220275
·
Received August 16, 2011
Report
- Report Number
- 1822565-2011-01891
- Event Type
- Injury
- Date Received
- August 16, 2011
- Date of Event
- June 30, 2011
- Report Date
- July 20, 2011
- Manufacturer
- ZIMMER INC
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
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 WAS REVISED FOR CYSTS IN THE MEDIAL FEMORAL CONDYLES AND ON THE LATERAL TIBIAL ALONG THE SCREW CHANNEL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NATURAL-KNEE II SYSTEM TIBIAL INSERT | JWH | ZIMMER INC | 1431766 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NATURAL-KNEE II SYSTEM SINTERLOCK POROUS COATED| CATALOG #621200230, LOT #1443870| NATURAL-KNEE II SYSTEM STEMMED TIBIAL BASEPLATE,| FEMORAL COMPONENT, CATALOG #621200030,| TI FULLY THREADED CANCELLOUS BONE SCREW,| CATALOG #430107050, LOT # UNK (QUANTITY 2)| LOT #1471539 |