FDA Adverse Event
Injury
Summary report: N
NEXGEN COMPLETE KNEE SOLUTION MINIMALLY INVASIVE SOLUTIONS TOTAL KNEE PROCEDURE
MDR report key: 1347276
·
Received March 20, 2009
Report
- Report Number
- 1822565-2009-00316
- Event Type
- Injury
- Date Received
- March 20, 2009
- Date of Event
- February 2, 2009
- Report Date
- February 12, 2009
- Manufacturer
- ZIMMER, INC.
- Product Code
- JWH
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HI, US
- Reporter Occupation
- OTHER
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 DEVICE WAS REVISED IN 2009, DUE TO THE TIBIAL COMPONENT BEING SIGNIFICANTLY LOOSE AND MEDIAL TIBIAL PLATEAU BONE LOSS. IMPLANT DATE IS UNK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEXGEN COMPLETE KNEE SOLUTION MINIMALLY INVASIVE SOLUTIONS TOTAL KNEE PROCEDURE | KNEE PROSTHESIS | JWH | ZIMMER, INC. | NA | 60553227 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Hospitalization| R |