FDA Adverse Event
Injury
Summary report: N
SMARTSET MV 40G - EO
MDR report key: 3932791
·
Received July 14, 2014
Report
- Report Number
- 1818910-2014-23292
- Event Type
- Injury
- Date Received
- July 14, 2014
- Date of Event
- June 18, 2014
- Report Date
- July 25, 2014
- Manufacturer
- DEPUY CMW 9610921
- Product Code
- LOD
- PMA / PMN Number
- PK081155
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
Description of Event or Problem · 1
PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL TRAY AT THE CEMENT/IMPLANT INTERFACE. DEPUY CEMENT WAS USED AT THE TIME OF ORIGINAL IMPLANTATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 409475 | SMARTSET MV 40G - EO | CEMENT / CEMENT ACCESSORY | LOD | DEPUY CMW 9610921 | 3350094 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Female | Required Intervention |