FDA Adverse Event
Malfunction
Summary report: N
LGN PS HIGH FLEX XLPE SZ 3-4 13MM
MDR report key: 6055771
·
Received October 25, 2016
Report
- Report Number
- 1020279-2016-00824
- Event Type
- Malfunction
- Date Received
- October 25, 2016
- Date of Event
- October 11, 2016
- Report Date
- October 13, 2016
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- JWH
- PMA / PMN Number
- K071071
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT WAS SUBMITTED IN ERROR. PLEASE DISREGARD MDR 1020279-2016-00824.
Description of Event or Problem · 1
IT WAS REPORTED THE INSERT WAS NOT FITTING WITH TIBIA. THERE WAS A 20 MIN DELAY. THERE WAS NO ADDITIONAL SAME SIZE INSERT SO 11MM INSERT WAS USED INSTEAD AS A BACKUP DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 706597 | LGN PS HIGH FLEX XLPE SZ 3-4 13MM | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/META | JWH | SMITH & NEPHEW, INC. | 16BT65729 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| O |