FDA Adverse Event
Injury
Summary report: N
CONSERVE(R) TOTAL A-CLASS HEAD
MDR report key: 2950655
·
Received February 8, 2013
Report
- Report Number
- 1043534-2013-00241
- Event Type
- Injury
- Date Received
- February 8, 2013
- Date of Event
- January 4, 2013
- Report Date
- January 10, 2013
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- JDL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, 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 1043534-2013-00240, 00242, 00243.
Additional Manufacturer Narrative · 1
CONCLUSION: NO CONCLUSION CAN BE DRAWN. THE COMPLAINT WAS REVIEWED. THE PRODUCT WAS DIMENSIONALLY INSPECTED AND PHOTOGRAPHIC IMAGES WERE MADE OF THE PRODUCT.(B)(4).
Description of Event or Problem · 1
ALLEGEDLY PATIENT PRESENTED WITH PAIN IN THE HIP AND A PREOP COCR LEVEL OF 4.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 54006 | CONSERVE(R) TOTAL A-CLASS HEAD | HIP COMPONENT, CODE:JDL | JDL | WRIGHT MEDICAL TECHNOLOGY, INC. | 106377461 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |