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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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


Premarket Reviews
ManufacturerDecision
ADVANCED BIO-SURFACES, INC.
  SUBSTANTIALLY EQUIVALENT 2
OSTEOIMPLANT TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
SULZER
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Implant, removal of 1131
Component(s), worn 569
Loose 549
Explanted 275
Unknown (for use when the device problem is not known) 184
Naturally worn 147
No Information 97
Other (for use when an appropriate device code cannot be identified) 66
Loss of or failure to bond 41
Fracture 39
Device, or device fragments remain in patient 38
Loose or intermittent connection 32
Loss of osseointegration 30
Break 29
Migration of device or device component 12
Device remains implanted 11
Fitting problem 9
Malfunction 9
Malposition of device 9
Displacement 8
Component(s), broken 7
Disengaged 6
Dislocated 6
No code available 6
Component missing 5
Dislodged or dislocated 4
Component incompatible 4
Metal shedding debris 3
Reaction 3
Pitted 3
Device Issue 3
Tear, rip or hole in device packaging 3
Incomplete or missing packaging 2
Size incorrect for patient 2
Disassembly 2
Detachment of device component 2
Foreign material 2
Failure to Adhere or Bond 1
Failure to discharge 1
Material discolored 1
Unstable 1
Screw head(s), incorrect 1
Difficult to remove 1
Defective component 1
User used incorrect product for intended use 1
Misassembled 1
Normal 1
Mechanical issue 1
Automatic injection system underinfusion 1
Deterioration of prosthesis 1
Device or device fragments location unknown 1
Sharp/jagged/rough/etched/scratched 1
Device, removal of (non-implant) 1
Patient-device incompatibility 1
Device markings issue 1
Total Device Problems 3366

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