FDA Adverse Event
Injury
Summary report: N
STAR TOTAL ANKLE REPLACEMENT
MDR report key: 4076377
·
Received September 2, 2014
Report
- Report Number
- 3003640913-2014-00064
- Event Type
- Injury
- Date Received
- September 2, 2014
- Date of Event
- August 14, 2014
- Report Date
- August 19, 2014
- Manufacturer
- SMALL BONE INNOVATIONS, INC.
- Product Code
- NTG
- PMA / PMN Number
- P050050
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
VISUAL EXAMINATION CONFIRMS SLIDING CORE MOBILE BEARING WAS FRACTURED. SLIDING CORE MOBILE BEARING DISLOCATION POSTERIOR; NO ROOT CAUSE HAS BEEN IDENTIFIED. THERE WERE NO DEVIATIONS REPORTED IN THE DHR FOR PART NO. 400-142, LOT NO. 0920104. ALL PARTS WERE RELEASED WITHIN SPECIFICATIONS.
Description of Event or Problem · 1
STAR TOTAL ANKLE REPLACEMENT SLIDING CORE MOBILE BEARING WAS EXCHANGED TO CORRECT IMPLANT DISLOCATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 532171 | STAR TOTAL ANKLE REPLACEMENT | SLIDING CORE MOBILE BEARING | NTG | SMALL BONE INNOVATIONS, INC. | 400-142 | 0920104 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Required Intervention |