FDA Adverse Event
Injury
Summary report: N
CONSERVE(R) TOTAL A-CLASS HEAD
MDR report key: 3201864
·
Received July 2, 2013
Report
- Report Number
- 1043534-2013-01103
- Event Type
- Injury
- Date Received
- July 2, 2013
- Report Date
- May 31, 2013
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- JDL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCLUSION: NO CONCLUSION CAN BE DRAWN. THE COMPLAINT AND PACKAGE INSERT WERE REVIEWED. THE PRODUCT WAS NOT RETURNED.(B)(4).
Additional Manufacturer Narrative · 1
THE INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2013-01102, 01104, 01105.
Description of Event or Problem · 1
ALLEGEDLY PATIENT REVISED FOR SYMPTOMATIC PAIN AND ELEVATED IONS DUE TO MOM BEARING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 302145 | CONSERVE(R) TOTAL A-CLASS HEAD | HIP COMPONENT, CODE:JDL | JDL | WRIGHT MEDICAL TECHNOLOGY, INC. | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |