FDA Adverse Event
Injury
Summary report: N
NEXGEN COMPLETE KNEE SOLUTION ROTATING HINGE KNEE FEMORAL COMPONENT
MDR report key: 1308545
·
Received February 6, 2009
Report
- Report Number
- 1822565-2009-00126
- Event Type
- Injury
- Date Received
- February 6, 2009
- Date of Event
- January 8, 2009
- Report Date
- January 8, 2009
- Manufacturer
- ZIMMER, INC.
- Product Code
- HRZ
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- 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 IMPLANTED IN EARLY 2008 AND WAS REVISED IN EARLY 2009, DUE TO THE LOCKING MECHANISM IN THE CENTER OF THE KNEE FRACTURING ALONG WITH THE LOCKING PIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEXGEN COMPLETE KNEE SOLUTION ROTATING HINGE KNEE FEMORAL COMPONENT | KNEE PROSTHESIS | HRZ | ZIMMER, INC. | NA | 60692919 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Hospitalization| R |