OtherHSH
OPTETRAK TIBIAL TRAY
Received Oct 24, 2012 · Event occurred Sep 24, 2012
Report 1038671-2012-00131 · MDR key 2818460
Device
Generic name
None
Manufacturer
Exactech, Inc.Product problems
- Break
- Naturally Worn
Patient
57 YR
- Pain
- Device Embedded In Tissue or Plaque
Narrative
Additional Manufacturer Narrative
ENGINEERING EVALUATION OF RETURNED DEVICE PENDING.
Description of Event or Problem
PRIMARY SURGERY OCCURRED BETWEEN 1998 AND 2002 (PT UNSURE OF DATE). REVISION DUE TO PAIN AND SUBLUXATION OF PATELLA. SURGEON REVIEW OF X-RAYS NOTED THAT POLY INSERT APPEARED TO BE WORN. PT WAS SCHEDULED FOR POLY EXCHANGE AND LATERAL RELEASE. DURING SURGERY, SURGEON FOUND THE TIBIAL TRAY TO BE BROKEN AND A METAL SHARD FROM THE TRAY WAS LODGED IN THE INSERT.