FDA Adverse Event
Injury
Summary report: N
PROFEMUR(R) MODULAR FEMORAL NECK
MDR report key: 3981138
·
Received August 5, 2014
Report
- Report Number
- 3010536692-2014-01022
- Event Type
- Injury
- Date Received
- August 5, 2014
- Date of Event
- May 28, 2014
- Report Date
- July 9, 2014
- Manufacturer
- MICROPORT ORTHOPEDICS INC.
- Product Code
- LWJ
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS EVENT OCCURRED IN (B)(6).
Description of Event or Problem · 1
ALLEGEDLY WHILST WALKING ON A STAIRCASE, THE PATIENT EXPERIENCED A SUDDEN WEAKNESS IN THE RIGHT LEG WHICH RESULTED IN A FALL. THE OUTCOME WAS A FRACTURE OF THE FEMORAL NECK WHICH NEEDED A STEM REPLACEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 456753 | PROFEMUR(R) MODULAR FEMORAL NECK | HIP COMPONENT | LWJ | MICROPORT ORTHOPEDICS INC. | 089922078 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |