FDA Adverse Event
Injury
Summary report: N
LEGION SCW LWDG S5 5D X 5P
MDR report key: 8929160
·
Received August 26, 2019
Report
- Report Number
- 1020279-2019-03184
- Event Type
- Injury
- Date Received
- August 26, 2019
- Date of Event
- July 24, 2019
- Report Date
- December 3, 2019
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- JWH
- UDI-DI
- 03596010545114
- PMA / PMN Number
- K041106
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 0
THE INFORMATION RECEIVED BY THE MANUFACTURER HAS BEEN RE-EVALUATED FOR MDR REPORTING. THE INFORMATION STATES THAT THIS DEVICE IS A CONCOMITANT, THEREFORE, IT WAS DETERMINED THAT THIS CASE DOES NOT MEET THE THRESHOLD FOR REPORTING AND IS A NON-REPORTABLE EVENT. IF FURTHER DETAILS ARE PROVIDED CONFIRMING THE OCCURRENCE OF A REPORTABLE EVENT, OUR FILES WILL BE UPDATED ACCORDINGLY AND A FURTHER REPORT SUBMITTED OUTLINING BOTH THE EVENT DETAILS AND OUR INVESTIGATIONS PERFORMED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 DUE TO INSTABILITY. A ZIMMER PRODUCT WAS IMPLANTED INSTEAD. FURTHER INFORMATION WAS REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 722955 | LEGION SCW LWDG S5 5D X 5P | PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY | JWH | SMITH & NEPHEW, INC. | 13MSM0229A | 03596010545114 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |