FDA Adverse Event
Injury
Summary report: N
PROFEMUR(R) MODULAR FEMORAL NECK
MDR report key: 6101856
·
Received November 15, 2016
Report
- Report Number
- 3010536692-2016-01391
- Event Type
- Injury
- Date Received
- November 15, 2016
- Date of Event
- September 17, 2016
- Report Date
- October 12, 2016
- Manufacturer
- MICROPORT ORTHOPEDICS INC.
- Product Code
- LWJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT WILL BE UPDATED WHEN INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION RECEIVED FROM LITIGATION: UPDATED IMPLANT AND EXPLANT DATES.
Description of Event or Problem · 1
ALLEGEDLY, THE PATIENT HAS EXPERIENCED A BROKEN FEMORAL NECK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 753881 | PROFEMUR(R) MODULAR FEMORAL NECK | HIP COMPONENT | LWJ | MICROPORT ORTHOPEDICS INC. | 119969851 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |