FDA Adverse Event
Injury
Summary report: N
CONSERVE(R) PLUS CUP
MDR report key: 2863586
·
Received December 10, 2012
Report
- Report Number
- 1043534-2012-01621
- Event Type
- Injury
- Date Received
- December 10, 2012
- Date of Event
- February 17, 2011
- Report Date
- November 7, 2012
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- KWA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THIS EVENT IS ADDRESSED IN THE PACKAGE INSERT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2012-01620, 01622, 01623.
Additional Manufacturer Narrative · 1
CONCLUSION: NO CONCLUSION CAN BE DRAWN. THE COMPLAINT AND PACKAGE INSERT WERE REVIEWED. THE PRODUCT WAS NOT RETURNED.
Description of Event or Problem · 1
ALLEGEDLY REVISED DUE TO MOM COMPLICATIONS. LEFT HIP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONSERVE(R) PLUS CUP | HIP COMPONENT, CODE:KWA | KWA | WRIGHT MEDICAL TECHNOLOGY, INC. | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |