FDA Adverse Event
Injury
Summary report: N
STAR TOTAL ANKLE REPLACEMENT
MDR report key: 4170507
·
Received October 9, 2014
Report
- Report Number
- 3003640913-2014-00072
- Event Type
- Injury
- Date Received
- October 9, 2014
- Date of Event
- September 10, 2014
- Report Date
- September 10, 2014
- Manufacturer
- SMALL BONE INNOVATIONS, INC.
- Product Code
- NTG
- PMA / PMN Number
- P050050
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL REMOVED COMPONENTS: SLIDING CORE MOBILE BEARING; MODEL#: 400-140, LOT#: 0913039; EXPIRATION DATE: 06/01/2014. DEVICE MANUFACTURE DATE: 06/2009. THERE WERE NO DEVIATIONS REPORTED IN THE DHRS FOR PART NO. 400-140, LOT NO. 0913039 AND PART NO. 400-254, LOT NO. 090303/0252. ALL RELEASED PARTS WERE WITHIN SPECIFICATION.
Description of Event or Problem · 1
STAR TOTAL ANKLE REPLACEMENT TALAR COMPONENT WAS EXCHANGED TO CORRECT SIZING ISSUE. THE SLIDING CORE MOBILE BEARING WAS ALSO EXCHANGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 637008 | STAR TOTAL ANKLE REPLACEMENT | NTG | SMALL BONE INNOVATIONS, INC. | 400-254 | 090303/0252 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Required Intervention |