FDA Adverse Event
Malfunction
Summary report: N
ITOTAL G2
MDR report key: 6072172
·
Received November 2, 2016
Report
- Report Number
- 3004153240-2016-00217
- Event Type
- Malfunction
- Date Received
- November 2, 2016
- Date of Event
- October 18, 2016
- Report Date
- November 2, 2016
- Manufacturer
- CONFORMIS, INC.
- Product Code
- JWH
- UDI-DI
- M572TCR1111111021
- PMA / PMN Number
- K142161
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A FIELD ACTION WAS INITIATED. REFERENCE REPORT NUMBER 3009844603-10/27/16-001-R.
Description of Event or Problem · 1
IMPLANT KIT SERIAL NUMBER (B)(4) CONTAINED A DISPOSABLE CUTTING GUIDE INSTRUMENT FOR SERIAL NUMBER (B)(4). THIS WAS IDENTIFIED DURING THE PROCEDURE. THE PATIENT WAS CONVERTED TO AN OFF THE SHELF KNEE IMPLANT SYSTEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 725883 | ITOTAL G2 | TOTAL KNEE REPLACEMENT SYSTEM | JWH | CONFORMIS, INC. | M572TCR1111111021 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR |