FDA Adverse Event
Death
Summary report: N
GENESISII TIBIAL INSERT AND FEMORAL COMPONENT
MDR report key: 4089131
·
Received September 15, 2014
Report
- Report Number
- 1020279-2014-00556
- Event Type
- Death
- Date Received
- September 15, 2014
- Date of Event
- September 2, 2014
- Report Date
- September 2, 2014
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- HSX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFORMATION WAS RECEIVED THAT THERE WAS A PATIENT DEATH. NO OTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME. DETAILS OF THE CAUSE OF DEATH HAVE BEEN REQUESTED.
Additional Manufacturer Narrative · 1
CORRECTION : CHECKED BOX INDICATED FOR DEATH. PATIENT DEATH WAS PREVIOUSLY REPORTED, HOWEVER BOX WAS NOT CHECKED.
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED. THE CAUSE IS UNKNOWN AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 568468 | GENESISII TIBIAL INSERT AND FEMORAL COMPONENT | HSX | SMITH & NEPHEW, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death| R |