FDA Adverse Event
Injury
Summary report: N
PROFEMUR(R) COCR NECK
MDR report key: 3910683
·
Received July 2, 2014
Report
- Report Number
- 3010536692-2014-00957
- Event Type
- Injury
- Date Received
- July 2, 2014
- Date of Event
- December 30, 2013
- Report Date
- June 2, 2014
- Manufacturer
- MICROPORT ORTHOPEDICS INC.
- Product Code
- KWA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS IS THE SAME EVENT AS 3010536692-2014-00913.
Description of Event or Problem · 1
ALLEGEDLY THE PATIENT WAS REVISED DUE TO MOM COMPLICATIONS (RIGHT).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 386371 | PROFEMUR(R) COCR NECK | HIP COMPONENT | KWA | MICROPORT ORTHOPEDICS INC. | 0801192124 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Required Intervention |