FDA Adverse Event
Injury
Summary report: N
NEXGEN RHK ART SURFACE WITH HINGE POST EXT
MDR report key: 3851149
·
Received May 23, 2014
Report
- Report Number
- 1822565-2014-00656
- Event Type
- Injury
- Date Received
- May 23, 2014
- Date of Event
- April 24, 2014
- Report Date
- April 24, 2014
- Manufacturer
- ZIMMER, INC.
- Product Code
- KRO
- 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 DUE TO INSTABILITY AND LIMITED MOBILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 309203 | NEXGEN RHK ART SURFACE WITH HINGE POST EXT | KRO | ZIMMER, INC. | 62409241 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Required Intervention |