FDA Adverse Event
Injury
Summary report: N
ITST FEMORAL NAIL
MDR report key: 3150132
·
Received May 30, 2013
Report
- Report Number
- 2648920-2013-00123
- Event Type
- Injury
- Date Received
- May 30, 2013
- Date of Event
- December 31, 2012
- Report Date
- April 28, 2013
- Manufacturer
- ZIMMER
- Product Code
- JDS
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JO
- 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 PATIENT WAS REVISED DUE TO THE NAIL BREAKING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 238049 | ITST FEMORAL NAIL | JDS | ZIMMER | 61234844 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Required Intervention |