FDA Adverse Event
Injury
Summary report: N
ADVANCE(R) TOT COND FEMORAL NON-POROUS
MDR report key: 4010335
·
Received August 14, 2014
Report
- Report Number
- 3010536692-2014-01128
- Event Type
- Injury
- Date Received
- August 14, 2014
- Date of Event
- July 4, 2013
- Report Date
- July 22, 2014
- Manufacturer
- MICROPORT ORTHOPEDICS INC.
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THIS IS THE SAME EVENT AS 3010536692-2014-01129, -01130, -01131. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE.
Additional Manufacturer Narrative · 1
THE COMPLAINT DATABASE WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT.
Description of Event or Problem · 1
ALLEGEDLY THE PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING TIBIA; INSTABILITY; MALALIGNMENT (RIGHT).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 487007 | ADVANCE(R) TOT COND FEMORAL NON-POROUS | KNEE COMPONENT | JWH | MICROPORT ORTHOPEDICS INC. | 106385521 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |