FDA Adverse Event
Injury
Summary report: N
SIGMA PS CEM FEM SZ4 R
MDR report key: 5999683
·
Received October 5, 2016
Report
- Report Number
- 1818910-2016-28763
- Event Type
- Injury
- Date Received
- October 5, 2016
- Date of Event
- September 28, 2016
- Report Date
- September 28, 2016
- Manufacturer
- DEPUY IRELAND 9616671
- Product Code
- NJL
- PMA / PMN Number
- P830055
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- HEALTH PROFESSIONAL
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. (B)(4). 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 PAIN AND STIFFNESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 650866 | SIGMA PS CEM FEM SZ4 R | KNEE FEMORAL COMPONENT | NJL | DEPUY IRELAND 9616671 | 3425399 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Required Intervention |