FDA Adverse Event
Injury
Summary report: N
CONTOUR
MDR report key: 6065179
·
Received October 28, 2016
Report
- Report Number
- 1020279-2016-00835
- Event Type
- Injury
- Date Received
- October 28, 2016
- Report Date
- October 3, 2016
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- JDH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
.
Additional Manufacturer Narrative · 1
THE ASSOCIATED COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO IMPLANT FRACTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 715584 | CONTOUR | HIP PROSTHESIS | JDH | SMITH & NEPHEW, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |