FDA Adverse Event
Injury
Summary report: N
DYNASTY® A-CLASS® 15DG POLY
MDR report key: 7969922
·
Received October 16, 2018
Report
- Report Number
- 3010536692-2018-01302
- Event Type
- Injury
- Date Received
- October 16, 2018
- Report Date
- October 16, 2018
- Manufacturer
- MICROPORT ORTHOPEDICS INC.
- Product Code
- LPH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS COMPLAINT WILL BE UPDATED ONCE INVESTIGATION IS COMPLETE. TREND WILL BE EVALUATED.
Description of Event or Problem · 1
ALLEGEDLY, PATIENT HAD HIP REPLACEMENT SURGERY ON (B)(6) 2017. PATIENT HAD REVISION SURGERY ON (B)(6) 2018 DUE TO LEG LENGTH ISSUES. REVISED ACETABULAR SHELL AND LINER FROM GROUP G TO GROUP D. REVISED FEMORAL HEAD FROM NECK LENGTH 0 TO -3.5 SHORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 809295 | DYNASTY® A-CLASS® 15DG POLY | HIP COMPONENT | LPH | MICROPORT ORTHOPEDICS INC. | DLXP-LG36 | 1685007 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |