FDA Adverse Event
Injury
Summary report: N
PROFEMUR(R) MODULAR FEMORAL NECK
MDR report key: 3770206
·
Received April 24, 2014
Report
- Report Number
- 3010536692-2014-00654
- Event Type
- Injury
- Date Received
- April 24, 2014
- Date of Event
- March 21, 2014
- Report Date
- March 28, 2014
- Manufacturer
- MICROPORT ORTHOPEDICS INC.
- Product Code
- LWJ
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- 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.
Description of Event or Problem · 1
ALLEGEDLY PT. PRESENTED COMPLAINING OF HAVING A STRANGE FEELING IN RIGHT HIP SEVERAL DAYS EARLIER. HE SAID HE HEARD A "POP" THE NEXT DAY AND HIS HIP WAS UNSTABLE. X-RAY CONFIRMED THE PROSTHESIS NECK HAD FRACTURED. REVISION SURGERY INVOLVED REMOVING STEM VIA ETO. A POLY LINER WAS PLACED IN THE DYNASTY SHELL REPLACING THE COCR LINER. ANOTHER MANUFACTURER'S REVISION STEM WAS USED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 249179 | PROFEMUR(R) MODULAR FEMORAL NECK | HIP COMPONENT | LWJ | MICROPORT ORTHOPEDICS INC. | 01976118 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Required Intervention |