FDA Adverse Event
Injury
Summary report: N
CONSERVE(R) PLUS SPIKED CUP
MDR report key: 2895549
·
Received January 3, 2013
Report
- Report Number
- 1043534-2013-00017
- Event Type
- Injury
- Date Received
- January 3, 2013
- Date of Event
- October 22, 2012
- Report Date
- December 10, 2012
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- KWA
- PMA / PMN Number
- K031963
- 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 WERE REVIEWED. THE PRODUCT WAS NOT RETURNED.EVIDENCE THAT PRODUCT IN SPECIFICATION WHEN USED.(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. THIS IS THE SAME EVENT AS 1043534-2013-00015, 00016, 00018.
Description of Event or Problem · 1
ALLEGEDLY REVISED DUE TO MOM COMPLICATIONS. RIGHT HIP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2897 | CONSERVE(R) PLUS SPIKED CUP | HIP COMPONENT, CODE:KWA | KWA | WRIGHT MEDICAL TECHNOLOGY, INC. | 07487299 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |