FDA Adverse Event
Injury
Summary report: N
UNKNOWN STAR TALAR
MDR report key: 6358507
·
Received February 24, 2017
Report
- Report Number
- 0008031020-2017-00080
- Event Type
- Injury
- Date Received
- February 24, 2017
- Date of Event
- January 31, 2017
- Report Date
- February 24, 2017
- Manufacturer
- STRYKER GMBH
- Product Code
- NTG
- PMA / PMN Number
- P050050
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE REPORTED DEVICE WAS MANUFACTURED AND DISTRIBUTED BY (B)(4) AND IMPLANTED PRIOR TO HOWMEDICA OSTEONICS CORP.¿S PURCHASE OF CERTAIN ASSETS OF (B)(4) ON AUGUST 1, 2014. STRYKER BECAME LEGAL MANUFACTURER OF THIS PRODUCT ON APRIL 1, 2015 AND HAS TAKEN THE RESPONSIBILITY FOR MEDICAL DEVICE REPORTING. DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED.
Description of Event or Problem · 1
STRYKER STAR ANKLE COMPONENTS WERE EXPLANTED AND NEW COMPONENTS WERE IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 140839 | UNKNOWN STAR TALAR | PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME | NTG | STRYKER GMBH | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |