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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-, femoral
Regulation Description Knee joint femoral (hemi-knee) metallic uncemented prosthesis.
Product CodeHSA
Regulation Number 888.3570
Device Class 3

Device Problems
Implant, removal of 430
Loose 393
Unknown (for use when the device problem is not known) 66
Explanted 62
No Information 39
Loss of or failure to bond 36
Device remains implanted 36
Other (for use when an appropriate device code cannot be identified) 34
Loose or intermittent connection 32
Loss of osseointegration 30
Fracture 21
Tear, rip or hole in device packaging 17
Break 15
Foreign material 13
Device, or device fragments remain in patient 12
Component(s), worn 11
Failure to Adhere or Bond 7
Malposition of device 7
Component(s), broken 5
Dislocated 5
No code available 4
Component incompatible 3
Disassembly 3
Metal shedding debris 3
Malfunction 3
Fitting problem 3
Component missing 2
Incomplete or missing packaging 2
Size incorrect for patient 2
Unstable 2
Material discolored 2
Displacement 2
Noise, Audible 2
Naturally worn 2
Dislodged or dislocated 1
Migration of device or device component 1
Pitted 1
Premature end-of-life indicator 1
User used incorrect product for intended use 1
Disengaged 1
Dislodged 1
Failure to osseointegrate 1
Total Device Problems 1314

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