FDA Adverse Event
Injury
Summary report: N
LEGION SCW LWDG S4 5D X 10P
MDR report key: 8307281
·
Received February 5, 2019
Report
- Report Number
- 1020279-2019-00456
- Event Type
- Injury
- Date Received
- February 5, 2019
- Date of Event
- January 14, 2019
- Report Date
- April 29, 2019
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- JWH
- UDI-DI
- 03596010545060
- PMA / PMN Number
- K041106
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 0
THE ASSOCIATED COMPLAINT DEVICE WAS NOT RETURNED. COMPLAINT WAS DUE TO USER ERROR. WITHOUT THE ACTUAL PRODUCT INVOLVED, OUR INVESTIGATION CANNOT PROCEED. IF THE DEVICE OR NEW INFORMATION IS RECEIVED IN THE FUTURE, THIS COMPLAINT CAN BE RE-OPENED. WE CONSIDER THIS INVESTIGATION CLOSED. CREDIT CANNOT BE ISSUED FOR THE DEVICE.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING SURGERY, AFTER IMPLANTED THE L-WEDGES, IT WAS REALIZED THAT THE IMPLANT WAS EXPIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 97488 | LEGION SCW LWDG S4 5D X 10P | PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY | JWH | SMITH & NEPHEW, INC. | 07DM01574 | 03596010545060 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |