FDA Adverse Event
Injury
Summary report: N
STAR TOTAL ANKLE REPLACEMENT
MDR report key: 3874020
·
Received June 5, 2014
Report
- Report Number
- 3003640913-2014-00040
- Event Type
- Injury
- Date Received
- June 5, 2014
- Date of Event
- May 8, 2014
- Report Date
- May 9, 2014
- Manufacturer
- SMALL BONE INNOVATIONS, INC.
- Product Code
- NTG
- PMA / PMN Number
- P050050
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL REMOVED COMPONENTS: COMMON DEVICE NAME: SLIDING CORE MOBILE BEARING, MODEL #: 400-140, LOT #: 1306010, EXPIRATION DATE: 12/01/2015. DEVICE MANUFACTURE DATE: 12/01/2010. THERE ARE NO DEVIATIONS REPORTED IN THE DHR FOR PART NO. 400-140, LOT 1306010. THE DHR FOR PART NO. 400-263, LOT 100325/0166. NOTE THAT 2 OUT OF 40 PIECES WERE DISCARDED AND 10 PIECES WERE SUBJECT TO RE-WORK; ALL RELEASED PARTS WERE WITHIN SPECIFICATION.
Description of Event or Problem · 1
STAR TOTAL ANKLE REPLACEMENT WAS REVISED DUE TO PATIENT EXPERIENCING MEDIAL PAIN. TIBIAL COMPONENT WAS REPLACED TO ADDRESS BASE PLATE LOOSENING, AND SLIDING CORE MOBILE BEARING WAS ALSO EXCHANGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 328837 | STAR TOTAL ANKLE REPLACEMENT | TIBIAL COMPONENT | NTG | SMALL BONE INNOVATIONS, INC. | 400-263 | 100325/0166 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Required Intervention |