FDA Adverse Event
Injury
Summary report: N
PROFEMUR(R) MODULAR FEMORAL NECK
MDR report key: 4111364
·
Received September 23, 2014
Report
- Report Number
- 3010536692-2014-01408
- Event Type
- Injury
- Date Received
- September 23, 2014
- Date of Event
- September 1, 2014
- Report Date
- September 1, 2014
- Manufacturer
- MICROPORT ORTHOPEDICS INC.
- Product Code
- LWJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS NOT COMPLETE; REPORT WILL BE UPDATED WHEN COMPLETE. TRENDS WILL BE EVALUATED. THIS EVENT OCCURRED IN (B)(6).
Description of Event or Problem · 1
ALLEGEDLY THE PT. STUMBLED OVER A SILL AND FELL ON LEFT HIP, BREAKING NECK COMPONENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 589881 | PROFEMUR(R) MODULAR FEMORAL NECK | HIP COMPONENT | LWJ | MICROPORT ORTHOPEDICS INC. | W1037279 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |