FDA Adverse Event
Injury
Summary report: N
PROFEMUR(R) MODULAR FEMORAL NECK
MDR report key: 4221144
·
Received November 3, 2014
Report
- Report Number
- 3010536692-2014-01549
- Event Type
- Injury
- Date Received
- November 3, 2014
- Date of Event
- January 15, 2010
- Report Date
- October 3, 2014
- Manufacturer
- MICROPORT ORTHOPEDICS INC.
- Product Code
- LWJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS IS THE SAME EVENT AS 3010536692-2014-01548, -01550. THIS REPORT WILL BE UPDATED ONCE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
ALLEGEDLY THE PATIENT WAS REVISED DUE TO MOM COMPLICATIONS AND INFECTION OF HIP (RIGHT).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 702463 | PROFEMUR(R) MODULAR FEMORAL NECK | HIP COMPONENT | LWJ | MICROPORT ORTHOPEDICS INC. | 116386167 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |