FDA Adverse Event
Injury
Summary report: N
STAR TOTAL ANKLE REPLACEMENT
MDR report key: 3778333
·
Received April 23, 2014
Report
- Report Number
- 3003640913-2014-00031
- Event Type
- Injury
- Date Received
- April 23, 2014
- Date of Event
- March 5, 2014
- Report Date
- March 12, 2014
- Manufacturer
- SMALL BONE INNOVATIONS, INC.
- Product Code
- NTG
- PMA / PMN Number
- P050050
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL REMOVED COMPONENTS: STAR TOTAL ANKLE REPLACEMENT, SLIDING CORE MOBILE BEARING, MODEL #: 400-140, LOT #: 0931065, EXPIRATION DATE: 04/01/2015, DATE OF IMPLANTATION: (B)(6)2011, DATE OF EXPLANTATION: (B)(6) 2014, DEVICE MANUFACTURE DATE: 03/2010. THERE WERE NO DEVIATIONS REPORTED IN THE DHR FOR PART NO. 400-140, LOT 0931065. THE DHR FOR PART NO. 400-257, LOT 090409/2355 NOTE THAT 1 OUT OF THE 30 PIECES WERE DISCARDED; 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 |
|---|---|---|---|---|---|---|---|
| 245855 | STAR TOTAL ANKLE REPLACEMENT | TALAR COMPONENT | NTG | SMALL BONE INNOVATIONS, INC. | 400-257 | 090409/2355 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Required Intervention |