FDA Adverse Event
Injury
Summary report: N
TALAR COMPONENT: SMALL (34MM X 35MM) LEFT
MDR report key: 5419155
·
Received February 9, 2016
Report
- Report Number
- 0008031020-2016-00054
- Event Type
- Injury
- Date Received
- February 9, 2016
- Date of Event
- March 13, 2014
- Report Date
- January 13, 2016
- Manufacturer
- STRYKER GMBH
- Product Code
- NTG
- PMA / PMN Number
- P050050
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE REPORTED DEVICE WAS MANUFACTURED AND DISTRIBUTED BY SMALL BONE INNOVATION, INC., MORRISVILLE PA AND IMPLANTED PRIOR TO HOWMEDICA OSTEONICS CORP.¿S PURCHASE OF CERTAIN ASSETS OF SBI ON (B)(6) 2014. STRYKER BECAME LEGAL MANUFACTURER OF THIS PRODUCT ON (B)(6) 2015 AND HAS TAKEN THE RESPONSIBILITY FOR MEDICAL DEVICE REPORTING. DEVICE REMAINS IMPLANTED. ADDITIONAL INFORMATION WAS REQUESTED AND IF RECEIVED WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. DEVICE REMAINS IMPLANTED.
Description of Event or Problem · 1
SUPERFICIAL SOFT TISSUE INFECTION, POSSIBLE SUTURE REACTION WITH SUPERIMPOSED CELLULITIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 82487 | TALAR COMPONENT: SMALL (34MM X 35MM) LEFT | PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME | NTG | STRYKER GMBH | 1001282460 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Required Intervention |