FDA Adverse Event
Injury
Summary report: N
KNEE FUSION FAN L 13MM X 80CM
MDR report key: 4243439
·
Received November 11, 2014
Report
- Report Number
- 1020279-2014-00688
- Event Type
- Injury
- Date Received
- November 11, 2014
- Date of Event
- June 4, 2013
- Report Date
- November 11, 2014
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- HWC
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER INDICATED THAT THERE IS NO PRODUCT/DEVICE TO BE RETURNED FOR INVESTIGATION ANALYSIS.
Description of Event or Problem · 1
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO AN IMPLANT FRACTURE.
Description of Event or Problem · 1
IT WAS REPORTED THE SURGEON REMOVED THE TEMPORARY SPACER AND ROD AND IMPLANTED THE NAIL AS PLANNED ON (B)(6) 2015.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 726314 | KNEE FUSION FAN L 13MM X 80CM | TRAUMA IMPLANT | HWC | SMITH & NEPHEW, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Required Intervention |