BIOPOLY® GREAT TOE HEMIARTHROPLASTY IMPLANT

Additional Manufacturer Narrative

A BIOPOLY GREAT TOE IMPLANT REVISION WAS REPORTED . IT WAS REPORTED THAT THE ORIGINAL IMPLANT WAS NOT FULLY SEATED AGAINST THE METATARSAL (PROTRUDING ABOUT 2MM) AT THE TIME OF THE REVISION. THE STEM WAS WELL INTEGRATED AND STILL FIXED TO BONE. THE IMPLANT WAS REVISED TO A SMALLER, 14MM BIOPOLY GREAT TOE IMPLANT WITH BONE CEMENT.. BIOPOLY NOTIFIED THE DISTRIBUTOR THAT IT IS POSSIBLE THAT THE IMPLANT MAY NOT HAVE BEEN FULLY SEATED UPON INITIAL INSERTION. BIOPOLY ADVISED ENSURING THAT THE DRILL IS ADVANCED FULLY UNTIL THE COLLAR CONTACTS THE BONE AS WELL AS ENSURING THAT THE IMPLANT IS PROGRESSIVELY TAMPED INTO PLACE USING THE PROVIDED INSERTION TAMP AND A MALLET TO FULLY SEAT THE IMPLANT IN FUTURE CASES. BIOPOLY CONFIRMED THAT USING BONE CEMENT FOR THE REVISION WAS APPROPRIATE, AS IT IS PART OF THE INDICATION FOR USE FOR THE DEVICE.

Description of Event or Problem

BIO POLY LEARNED FROM A SALES REP ABOUT A REVISION SURGERY TO REMOVE A BIOPOLY GREAT TOE IMPLANT AND REVISE TO A BIOPOLY GREAT TOE IMPLANT.