FDA Adverse Event
Injury
Summary report: N
PROFEMUR(R) MODULAR FEMORAL NECK
MDR report key: 4233740
·
Received November 6, 2014
Report
- Report Number
- 3010536692-2014-01564
- Event Type
- Injury
- Date Received
- November 6, 2014
- Date of Event
- September 25, 2012
- Report Date
- October 2, 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
THE COMPLAINT DATABASE WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT.
Additional Manufacturer Narrative · 1
THIS IS THE SAME EVENT AS 3010536692-2014-01542_01, -01563, -01565. THIS REPORT WILL BE UPDATED ONCE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
ALLEGEDLY, THE PATIENT WAS REVISED DUE PAIN, DISCOMFORT, DYSFUNCTION AND OTHER SYMPTOMS; ALSO DISEASED JOINT TISSUE AND FLUIDS AS WELL AS FRETTING AND CORROSION AT JUNCTION INTERFACE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 715679 | PROFEMUR(R) MODULAR FEMORAL NECK | HIP COMPONENT | LWJ | MICROPORT ORTHOPEDICS INC. | 068580750 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Required Intervention |