FDA Adverse Event
Injury
Summary report: N
CONSERVE(R) FEMORAL HEAD
MDR report key: 3130393
·
Received May 24, 2013
Report
- Report Number
- 1043534-2013-00921
- Event Type
- Injury
- Date Received
- May 24, 2013
- Date of Event
- March 12, 2013
- Report Date
- April 24, 2013
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- KWA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- 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 1043534-2013-00920. THIS EVENT OCCURRED IN (B)(6).
Additional Manufacturer Narrative · 1
CONCLUSION: NO CONCLUSION CAN BE DRAWN. THE COMPLAINT AND PACKAGE INSERT WERE REVIEWED. THE PRODUCT WAS NOT RETURNED.(B)(4).
Description of Event or Problem · 1
ALLEGEDLY SURGEON PERFORMED THE REVISION SURGERY (B)(6) 2013, BECAUSE THE PATIENT WAS DOUBTED ARMD ISSUE BY MOM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 231752 | CONSERVE(R) FEMORAL HEAD | HIP COMPONENT, CODE:KWA | KWA | WRIGHT MEDICAL TECHNOLOGY, INC. | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |