FDA Adverse Event
Injury
Summary report: N
TRABECULAR METAL FEMORAL STEM
MDR report key: 3893992
·
Received June 10, 2014
Report
- Report Number
- 1822565-2014-00720
- Event Type
- Injury
- Date Received
- June 10, 2014
- Date of Event
- May 14, 2014
- Report Date
- May 21, 2014
- Manufacturer
- ZIMMER INC
- Product Code
- LPH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- 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 THE PATIENT WAS REVISED DUE TO A PROXIMAL FEMORAL FRACTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 343446 | TRABECULAR METAL FEMORAL STEM | LPH | ZIMMER INC | 62489514 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |