D
Patient 1
INDEX SURGERY: (B)(6) 2010. REVISION OF OPTETRAK KNEE COMPONENTS - REASON NOT REPORTED. THIS EVENT OCCURRED OUTSIDE OF THE US, IN (B)(6) AND WAS DISCOVERED AS PART OF ACTIVE SURVEILLANCE.
MAUDE MDR 4863074
- MDR report key
- 4863074
- Report number
- 1038671-2015-00281
- Event key
- 0
- Event type
- 3
- Date of event
- 2015-04-07
- Date received
- 2015-06-19
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- GRAHAM CUTHBERT
- Address
- 2320 N.W. 66TH CT. GAINESVILLE FL 32653 US
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | OPTETRAK TIBIAL TRAY | TIBIAL TRAY | EXACTECH, INC. | HSH | 200-04-33 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-06-19 | 0 |
Event Narratives#
N
Patient 1
THE CONTRIBUTION OF THE DEVICES TO THE EXPERIENCE REPORTED COULD NOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION. ADDITIONALLY, THE DEVICE SPECIFIC IDENTIFICATION INFO WAS NOT PROVIDED, PRECLUDING A REVIEW OF THE DEVICE HISTORY RECORD.