FDA Adverse Event
Injury
Summary report: N
PROFEMUR(R) MODULAR FEMORAL NECK
MDR report key: 3844066
·
Received June 2, 2014
Report
- Report Number
- 3010536692-2014-00877
- Event Type
- Injury
- Date Received
- June 2, 2014
- Date of Event
- March 24, 2014
- Report Date
- May 15, 2014
- Manufacturer
- MICROPORT ORTHOPEDICS INC.
- Product Code
- LWJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS NOT COMPLETE. REPORT WILL BE UPDATED.
Description of Event or Problem · 1
ALLEGEDLY THE PATIENT WAS REVISED DUE TO AN ALLEGED NECK FRACTURE THAT OCCURRED WHILE THE PATIENT WAS AT WORK (LEFT).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 322344 | PROFEMUR(R) MODULAR FEMORAL NECK | HIP COMPONENT | LWJ | MICROPORT ORTHOPEDICS INC. | 075235988 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Required Intervention |