FDA Adverse Event
Injury
Summary report: N
ADVANCE(R) II TIBIAL BASE
MDR report key: 5162636
·
Received October 20, 2015
Report
- Report Number
- 3010536692-2015-01861
- Event Type
- Injury
- Date Received
- October 20, 2015
- Date of Event
- May 22, 2015
- Report Date
- October 12, 2015
- Manufacturer
- MICROPORT ORTHOPEDICS INC.
- Product Code
- HRY
- PMA / PMN Number
- K960617
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION IS NOT COMPLETE. THE TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 3010536692-2015-01860 AND 01862. THIS EVENT OCCURRED IN (B)(6).
Additional Manufacturer Narrative · 1
THE COMPLAINT DATABASE WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT.
Description of Event or Problem · 1
ALLEGEDLY REVISED DUE TO INFECTION (RIGHT).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 693475 | ADVANCE(R) II TIBIAL BASE | KNEE COMPONENT | HRY | MICROPORT ORTHOPEDICS INC. | 078651100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |