FDA Adverse Event
Injury
Summary report: N
DYNASTY(R) A-CLASS(R) POLY LINER
MDR report key: 3922308
·
Received July 9, 2014
Report
- Report Number
- 3010536692-2014-00973
- Event Type
- Injury
- Date Received
- July 9, 2014
- Date of Event
- July 8, 2013
- Report Date
- June 12, 2014
- Manufacturer
- MICROPORT ORTHOPEDICS INC.
- Product Code
- LPH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- 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
INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THIS IS THE SAME EVENT AS 3010536692-2014-00972, -00974, 00975, 00976. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
ALLEGEDLY THE PATIENT WAS REVISED DUE TO DISLOCATION (LEFT).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 400244 | DYNASTY(R) A-CLASS(R) POLY LINER | HIP COMPONENT | LPH | MICROPORT ORTHOPEDICS INC. | 1477565 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Required Intervention |