OtherHSH
OPTETRAK
Received Jul 17, 2013 · Event occurred Apr 18, 2013
Report 1038671-2013-00069 · MDR key 3246706
Device
Product problems
- Disassembly
- Fracture
Patient
Not reported
- Osteolysis
Narrative
Description of Event or Problem
REVISION OF KNEE COMPONENTS. THE SCREW FOR THE TIBIAL STEM EXTENSION FRACTURED DUE TO STRESS SHIELDING CAUSING THE STEM EXTENSION TO DISASSEMBLE. SURGEON NOTED THAT SEVERE OSTEOLYSIS AND LACK OF BONE STOCK IN THE UPPER TIBIA WERE AN ISSUE.
Additional Manufacturer Narrative
THE CONTRIBUTION OF THE DEVICES TO THE REPORTED EXPERIENCE COULD NOT BE DETERMINED AS THE DEVICES WERE NOT AVAILABLE FOR EVAL.