FDA Adverse Event
Injury
Summary report: N
SUPERPATH(TM) CUP IMPACTOR
MDR report key: 5999385
·
Received October 5, 2016
Report
- Report Number
- 3010536692-2016-01238
- Event Type
- Injury
- Date Received
- October 5, 2016
- Date of Event
- July 20, 2016
- Report Date
- September 27, 2016
- Manufacturer
- MICROPORT ORTHOPEDICS INC.
- Product Code
- HWA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
REPORTED IN ERROR.
Additional Manufacturer Narrative · 1
THIS REPORT WILL BE UPDATED WHEN INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.
Description of Event or Problem · 1
ALLEGEDLY, DURING THE SURGERY THE INSTRUMENTS WERE DAMAGED. DURING THE BROACHING PHASE, THE FEMORAL SIDE OF THE DISTAL PART OF THE INSTRUMENT WAS BROKEN. THE THREADED CUP IMPACTOR WAS DAMAGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 650918 | SUPERPATH(TM) CUP IMPACTOR | HIP INSTRUMENT | HWA | MICROPORT ORTHOPEDICS INC. | 1331496 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |