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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 394
Unknown (for use when the device problem is not known) 66
Explanted 63
Loss of or failure to bond 37
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
No Information 28
Fracture 21
Tear, rip or hole in device packaging 17
Foreign material 13
Break 13
Device, or device fragments remain in patient 12
Component(s), worn 11
Malposition of device 7
Component(s), broken 5
Dislocated 5
Component incompatible 3
Fitting problem 3
Disassembly 3
Metal shedding debris 3
No code available 3
Malfunction 3
Displacement 2
Noise, Audible 2
Naturally worn 2
Component missing 2
Size incorrect for patient 2
Unstable 2
Failure to Adhere or Bond 2
Material discolored 2
Incomplete or missing packaging 2
Failure to osseointegrate 1
Migration of device or device component 1
Pitted 1
User used incorrect product for intended use 1
Disengaged 1
Dislodged 1
Premature end-of-life indicator 1
Total Device Problems 1297

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