FDA Adverse Event
Injury
Summary report: N
DYNASTY® A-CLASS® STD POLY LINER 36MM GROUP G
MDR report key: 14748875
·
Received June 20, 2022
Report
- Report Number
- 3010536692-2022-00223
- Event Type
- Injury
- Date Received
- June 20, 2022
- Report Date
- August 9, 2022
- Manufacturer
- MICROPORT ORTHOPEDICS INC.
- Product Code
- JDI
- UDI-DI
- M684DLXPGG361
- PMA / PMN Number
- K070785
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THIS EVENT WILL BE UPDATED ONCE THE INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.
Description of Event or Problem · 0
ALLEGEDLY, REVISED FOR INSTABILITY TO LARGER HEAD. THE FOLLOWING PRODUCTS WERE NOT REVISED: PRODUCT ID: DBFPGG62 DYNASTY BIOFOAM SHELL 62MM, LOT: 1700901, QTY: 1. PRODUCT ID: 18080302 CANCELLOUS SELF-TAPPING BONE SCREW 6.5X2.5, LOT: 1805477, QTY: 1. PRODUCT ID: PRTLEL30 PROFEMUR TL CLASSIC 10 VARUS LONG NECK, LOT: 1873812, QTY: 1.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1737524 | DYNASTY® A-CLASS® STD POLY LINER 36MM GROUP G | HIP COMPONENT | JDI | MICROPORT ORTHOPEDICS INC. | DLXPGG36 | 1812759 | M684DLXPGG361 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Male | Required Intervention |