FDA Adverse Event
Injury
Summary report: N
DYNASTY(R) A-CLASS(R) POLY LINER
MDR report key: 2830888
·
Received November 13, 2012
Report
- Report Number
- 1043534-2012-01537
- Event Type
- Injury
- Date Received
- November 13, 2012
- Date of Event
- October 12, 2012
- Report Date
- October 15, 2012
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- LPH
- PMA / PMN Number
- K061547
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCLUSION: NO CONCLUSION CAN BE DRAWN.THE COMPLAINT WAS REVIEWED. THE PRODUCT WAS NOT RETURNED.EVIDENCE THAT PRODUCT IN SPECIFICATION WHEN USED.(B)(4).
Additional Manufacturer Narrative · 1
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 1043534-2012-01536, 01538, 01539, 01540.
Description of Event or Problem · 1
ALLEGEDLY PATIENT WAS SQUEAKING. POLY LINER HAD DISENGAGED FROM THE CUP. REVISED CUP, LINER, NECK, HEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DYNASTY(R) A-CLASS(R) POLY LINER | HIP COMPONENT, CODE:LPH | LPH | WRIGHT MEDICAL TECHNOLOGY, INC. | 0301082994 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |