FDA Adverse Event
Injury
Summary report: N
PERFERCTA(R) RS II STANDARD FLARE STEM
MDR report key: 3171034
·
Received June 14, 2013
Report
- Report Number
- 1043534-2013-01049
- Event Type
- Injury
- Date Received
- June 14, 2013
- Date of Event
- December 13, 2012
- Report Date
- May 28, 2013
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- LPH
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2013-01047, 01048.
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 DISLOCATION OF HIP AND METALLOSIS REQUIRING REVISION SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 270767 | PERFERCTA(R) RS II STANDARD FLARE STEM | HIP COMPONENT, CODE:LPH | LPH | WRIGHT MEDICAL TECHNOLOGY, INC. | 06348546 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Required Intervention |