FDA Adverse Event
Injury
Summary report: N
PROCOTYL(R) E SHELL
MDR report key: 3133784
·
Received May 29, 2013
Report
- Report Number
- 1043534-2013-00938
- Event Type
- Injury
- Date Received
- May 29, 2013
- Date of Event
- August 12, 2009
- Report Date
- April 25, 2013
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- KWA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
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 THE (B)(6).
Additional Manufacturer Narrative · 1
CONCLUSION: NO CONCLUSION CAN BE DRAWN. THE COMPLAINT WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT. THE PACKAGE INSERT WAS ALSO REVIEWED. THE PRODUCT WAS NOT RETURNED.(B)(4).
Description of Event or Problem · 1
ALLEGEDLY CUP REVISED DUE TO ASEPTIC LOOSENING, DISLOCATION/SUBLUXATION AND PAIN. BMI: 25.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 234191 | PROCOTYL(R) E SHELL | HIP COMPONENT, CODE:KWA | KWA | WRIGHT MEDICAL TECHNOLOGY, INC. | X05401588 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |