FDA Adverse Event
Injury
Summary report: N
CONSERVE(R) HIP
MDR report key: 2970596
·
Received February 20, 2013
Report
- Report Number
- 1043534-2013-00368
- Event Type
- Injury
- Date Received
- February 20, 2013
- Date of Event
- October 9, 2012
- Report Date
- January 22, 2013
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- KWA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCLUSION: NO CONCLUSION CAN BE DRAWN. THE COMPLAINT AND PACKAGE INSERT WAS REVIEWED. THE PRODUCT WAS NOT RETURNED.(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.
Description of Event or Problem · 1
ALLEGEDLY REVISED DUE TO MOM COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 74602 | CONSERVE(R) HIP | HIP COMPONENT, CODE:KWA | KWA | WRIGHT MEDICAL TECHNOLOGY, INC. | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Required Intervention |