FDA Adverse Event
Injury
Summary report: N
JOURNEY UNI TIBIAL BASE LM/RL SZ 3
MDR report key: 6106392
·
Received November 16, 2016
Report
- Report Number
- 1020279-2016-00882
- Event Type
- Injury
- Date Received
- November 16, 2016
- Date of Event
- February 3, 2015
- Report Date
- April 11, 2017
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- HSX
- PMA / PMN Number
- K102069
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED A REVISION SURGERY WAS PERFORMED ON THE LEFT KNEE DUE TO COLLAPSE OF THE TIBIAL PLATE AND DEGENERATIVE CHANGES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 756943 | JOURNEY UNI TIBIAL BASE LM/RL SZ 3 | PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER | HSX | SMITH & NEPHEW, INC. | 12GM04722 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Hospitalization| R | JOURNEY FEMORAL HEAD PART#71422344 LOT#13DM18720| JOURNEY TIBIAL INSERT PART#71422251 LOT#13AM1095J |