FDA Adverse Event
Death
Summary report: N
SMARTSET MV ENDURANCE
MDR report key: 2431567
·
Received January 30, 2012
Report
- Report Number
- 1818910-2012-02705
- Event Type
- Death
- Date Received
- January 30, 2012
- Report Date
- December 30, 2011
- Manufacturer
- DEPUY CMW
- Product Code
- LOD
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.
Additional Manufacturer Narrative · 1
UNDETERMINED : INSUFFICIENT INFORMATION. PRODUCT CODE AND LOT NUMBER UNKNOWN. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE. THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.
Description of Event or Problem · 1
HAPPENED WHILE INSERTING THE FINAL FEMORAL IMPLANT AFTER RETROGRADE CEMENT FILLING INTO THE FEMORAL CANAL. THE SURGEON CLAIMS THAT EVENTS HAPPENED FOLLOWING THE USE OF THE REPORTED PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SMARTSET MV ENDURANCE | BONE CEMENT | LOD | DEPUY CMW | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |