FDA Adverse Event
Injury
Summary report: N
UNKNOWN_SELZACH_PRODUCT
MDR report key: 5316366
·
Received December 21, 2015
Report
- Report Number
- 0008031020-2015-00550
- Event Type
- Injury
- Date Received
- December 21, 2015
- Date of Event
- November 27, 2015
- Report Date
- December 1, 2015
- 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 SMALL BONE (B)(4) INNOVATION, INC., 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 WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. UNKNOWN 400-14XF STAR. DEVICE WILL NOT BE RETURNED
Description of Event or Problem · 1
PATIENT WAS REVISED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 840466 | UNKNOWN_SELZACH_PRODUCT | PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME | NTG | STRYKER GMBH | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |