FDA Adverse Event
Injury
Summary report: N
CONSERVE(R) PLUS BFH TOTAL HIP
MDR report key: 3115991
·
Received May 16, 2013
Report
- Report Number
- 1043534-2013-00777
- Event Type
- Injury
- Date Received
- May 16, 2013
- Report Date
- March 28, 2013
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- KWA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE COMPLAINT DATABASE WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT.
Additional Manufacturer Narrative · 1
THE 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 EVENT OCCURRED IN (B)(6).
Description of Event or Problem · 1
ALLEGEDLY PRESENTED AT THE JAPANESE ORTHOPAEDIC SOCIETY MEETING IN MARCH. A POWERPOINT SERIES OF THA WITH CONSERVE PHF ARTICULATION. TWENTY FIVE CASES OF TISSUE REACTION CONFIRMED WITH MARS MRI ONLY THREE REVISED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 217224 | CONSERVE(R) PLUS BFH TOTAL HIP | HIP COMPONENT, CODE:KWA | KWA | WRIGHT MEDICAL TECHNOLOGY, INC. | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |