FDA Adverse Event
Injury
Summary report: N
SWANSON TRAPEZIUM IMPLANT
MDR report key: 1603711
·
Received February 4, 2010
Report
- Report Number
- 1043534-2010-00032
- Event Type
- Injury
- Date Received
- February 4, 2010
- Date of Event
- December 10, 2009
- Report Date
- January 27, 2010
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- KYI
- PMA / PMN Number
- K864489
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. ALTHOUGH ATTEMPTS HAVE BEEN MADE, THE PRODUCT WILL NOT BE RETURNED FOR EVAL. THE EVENT CODES ARE ADDRESSED IN THE PACKAGE INSERT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
ALLEGEDLY PT HAS CHRONIC PAIN, SWELLING, AND SYNOVITIS IN LEFT THUMB SEVERAL MONTHS AFTER THE SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SWANSON TRAPEZIUM IMPLANT | KYI | WRIGHT MEDICAL TECHNOLOGY, INC. | NA | 049852474 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Hospitalization| R |