FDA Adverse Event
Injury
Summary report: N
CONSERVE(R) TOTAL A-CLASS HEAD
MDR report key: 2832307
·
Received November 14, 2012
Report
- Report Number
- 1043534-2012-01552
- Event Type
- Injury
- Date Received
- November 14, 2012
- Date of Event
- October 17, 2012
- Report Date
- October 18, 2012
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- JDL
- PMA / PMN Number
- K051348
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, 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. (B)(4): EVIDENCE THAT PRODUCT IN SPECIFICATION WHEN USED.
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 1043534-2012-01551.
Description of Event or Problem · 1
ALLEGEDLY CUP AND HEAD WERE EXPLANTED DUE TO MOM ISSUES. A COMPETITOR'S DUAL MOBILITY CUP WAS IMPLANTED WITH OUR 28MM HEAD. ISSUE AND IMPLANTS WERE COLLECTED FOR LAWYER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONSERVE(R) TOTAL A-CLASS HEAD | HIP COMPONENT, CODE:JDL | JDL | WRIGHT MEDICAL TECHNOLOGY, INC. | 046336291 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |