BIOPOLY® GREAT TOE HEMIARTHROPLASTY IMPLANT

Description of Event or Problem

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

Additional Manufacturer Narrative

THE IMPLANT WAS RETURNED AND INSPECTED. THE POROUS PORTION OF THE STEM SHOWED SIGNS OF BONE INGROWTH, INDICATING THAT THE IMPLANT WAS WELL FIXED. THIS WAS FURTHER SUPPORTED BECAUSE THE ARTICULATING SURFACE OF THE IMPLANT HAD GOUGES IN THE SURFACE, APPARENTLY FROM A TOOL USED TO EXTRACT THE IMPLANT. THE IMPLANT SHOWED SIGNS OF MACRO WEAR, INDICATING THAT IT WAS LIKELY ARTICULATING WITH EXCESSIVE FORCE AGAINST ROUGHENED BONE (I.E. POTENTIALLY OSTEOPHYTES ON THE PROXIMAL PHALANX). THE IFU WARNS THAT ARTICULATING THE IMPLANT AGAINST NON-CARTILAGE SURFACES CAN LEAD TO IMPLANT DAMAGE. FROM THIS INVESTIGATION, IT APPEARS THAT THESE TWO FACTORS (OVERSTUFFED/TIGHT JOINT AND NON-CARTILAGE ARTICULATION) COULD HAVE LED TO MACRO WEAR AND ULTIMATELY A STIFF/PAINFUL JOINT.