FDA Adverse Event
Injury
Summary report: N
DYNASTY(R) A-CLASS(R) POLY LINER
MDR report key: 3013416
·
Received March 20, 2013
Report
- Report Number
- 1043534-2013-00571
- Event Type
- Injury
- Date Received
- March 20, 2013
- Date of Event
- January 14, 2013
- Report Date
- February 18, 2013
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- JDL
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2013-00570, 00572, 00573.
Additional Manufacturer Narrative · 1
CONCLUSION: NO DEVICE FAILURE. THE COMPLAINT WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT. THE PRODUCT WAS NOT RETURNED. EVIDENCE THAT PRODUCT IN SPECIFICATION WHEN USED.
Description of Event or Problem · 1
ALLEGEDLY PATIENT COMPLAINT OF NOT FEELING RIGHT AND PAIN. SURGEON PERFORMED A PARTIAL REVISION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 116160 | DYNASTY(R) A-CLASS(R) POLY LINER | HIP COMPONENT, CODE:JDL | JDL | WRIGHT MEDICAL TECHNOLOGY, INC. | 0411349032 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |