FDA Adverse Event
Injury
Summary report: N
UNKNOWN X/L TAPER KINECTIV FEMORAL STEM
MDR report key: 1960993
·
Received January 11, 2011
Report
- Report Number
- 1822565-2011-00034
- Event Type
- Injury
- Date Received
- January 11, 2011
- Report Date
- December 15, 2010
- Manufacturer
- ZIMMER, INC.
- Product Code
- KWA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- 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 WAS REPORTED THAT THE DEVICE WAS IMPLANTED IN (B)(6) 2008 AND THAT THE PT WAS REVISED SOMETIME BEFORE (B)(6) 2010 FOR IMPINGEMENT AND SUBSEQUENT DISLOCATION OF THE HIP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN X/L TAPER KINECTIV FEMORAL STEM | HIP PROSTHESIS | KWA | ZIMMER, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |