FDA Adverse Event
Injury
Summary report: N
CONSERVE(R) PLUS CUP
MDR report key: 1843121
·
Received September 23, 2010
Report
- Report Number
- 1043534-2010-00389
- Event Type
- Injury
- Date Received
- September 23, 2010
- Date of Event
- April 17, 2009
- Report Date
- July 8, 2011
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- KWA
- PMA / PMN Number
- K021349
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THE DEVICE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. ALTHOUGH SEVERAL ATTEMPTS HAVE BEEN MADE, THE USER FACILITY HAS NOT BEEN IDENTIFIED TO DATE. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2010-00388, 00390, 00391.
Additional Manufacturer Narrative · 1
CONCLUSION: NO CONCLUSION CAN BE DRAWN.PRODUCT NOT RETURNED. COMPLAINT HISTORY REVIEWED. DEVICE HISTORY RECORD REVIEWED.EVIDENCE THAT PRODUCT IN SPEC WHEN USED. USE OF DEVICE COULD NOT BE DETERMINED.
Description of Event or Problem · 1
ALLEGEDLY REVISED DUE TO PAIN.
Description of Event or Problem · 1
ALLEGEDLY REVISED DUE TO PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONSERVE(R) PLUS CUP | HIP COMPONENT | KWA | WRIGHT MEDICAL TECHNOLOGY, INC. | 086365167 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Hospitalization| R |