Table 1.

Assigned subgroups for the different terms of adverse reports mentioned in the MAUDE database

Assigned subgroups	MAUDE terminology
Aseptic loosening	Severe osteolysis
	Loose implant
	Subsidence
Infection	Superficial infection
	Deep infection
	Deep sepsis
Alignment/mechanical issues	Instability
	Malalignment
	Malposition
Implant/instrumentation problems	Pin/screw/drill/reamer breakage
	Tibial stem breakage
	Implant dislodgement
	Alignment guide problems
	Custom jig problems
Impingement	Soft tissue impingement
	Bony impingement
	Heterotopic ossification
	Gutter tightness
Polyethylene-related problems	Loose poly
	Small/large poly
	Fractured poly
	Poly dislodgement
	Poly wear
Fractures	Fracture of medial malleolus
	Fracture of lateral malleolus
	Periprosthetic fractures of tibia/talus
Packaging/availability problems	Package-partially opened
	Expired date
	Late arrival of inventory