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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-, patellar resurfacing, uncemented
Regulation Description Knee joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis.
Product CodeHTG
Regulation Number 888.3580
Device Class 2


Premarket Reviews
ManufacturerDecision
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Implant, removal of 280
Component(s), worn 148
Naturally worn 90
No Information 83
Loose 59
Unknown (for use when the device problem is not known) 49
Loss of or failure to bond 27
Fracture 24
Loose or intermittent connection 20
Break 18
Other (for use when an appropriate device code cannot be identified) 17
Fitting problem 16
Disassembly 16
Explanted 15
No code available 11
Loss of osseointegration 6
Component(s), broken 6
Dislocated 3
Device remains implanted 3
Malfunction 3
Malposition of device 3
Metal shedding debris 2
Material discolored 2
Disengaged 1
Detachment of device component 1
Replace 1
Seal, incorrect 1
Material separation 1
Size incorrect for patient 1
Displacement 1
Material erosion 1
Foreign material 1
Device Issue 1
Connection issue 1
Dislodged or dislocated 1
Total Device Problems 913

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