TPLC - Total Product Life Cycle

Device	prosthesis, knee, hemi-, tibial, resurfacing (uncemented)
Regulation Description	Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis.
Product Code	HSH
Regulation Number	888.3590
Device Class	2

Device Problems
Implant, removal of	1130
Component(s), worn	569
Loose	549
Explanted	275
Unknown (for use when the device problem is not known)	184
Naturally worn	147
No Information	93
Other (for use when an appropriate device code cannot be identified)	66
Loss of or failure to bond	40
Fracture	39
Device, or device fragments remain in patient	38
Loose or intermittent connection	33
Loss of osseointegration	30
Break	29
Migration of device or device component	12
Device remains implanted	11
Fitting problem	9
Malposition of device	9
Malfunction	9
Displacement	8
Component(s), broken	7
Disengaged	6
Dislocated	6
Dislodged or dislocated	5
Component missing	5
No code available	4
Component incompatible	4
Pitted	3
Tear, rip or hole in device packaging	3
Metal shedding debris	3
Reaction	3
Disassembly	2
Size incorrect for patient	2
Device Issue	2
Foreign material	2
Incomplete or missing packaging	2
Difficult to remove	1
User used incorrect product for intended use	1
Patient-device incompatibility	1
Device, removal of (non-implant)	1
Failure to Adhere or Bond	1
Screw head(s), incorrect	1
Unstable	1
Sharp/jagged/rough/etched/scratched	1
Defective component	1
Detachment of device component	1
Material discolored	1
Normal	1
Failure to discharge	1
Mechanical issue	1
Deterioration of prosthesis	1
Device or device fragments location unknown	1
Misassembled	1
Automatic injection system underinfusion	1
Device markings issue	1
Total Device Problems	3358