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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
Device remains implanted 36
Loss of or failure to bond 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 14
Foreign material 13
Device, or device fragments remain in patient 12
Component(s), worn 11
Malposition of device 7
Failure to Adhere or Bond 7
Dislocated 5
Component(s), broken 5
No code available 4
Disassembly 3
Metal shedding debris 3
Malfunction 3
Fitting problem 3
Component incompatible 3
Incomplete or missing packaging 2
Size incorrect for patient 2
Displacement 2
Naturally worn 2
Noise, Audible 2
Component missing 2
Material discolored 2
Unstable 2
Migration of device or device component 1
Pitted 1
Failure to osseointegrate 1
Dislodged or dislocated 1
Premature end-of-life indicator 1
Disengaged 1
Dislodged 1
User used incorrect product for intended use 1
Total Device Problems 1313

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