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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, hip, femoral, resurfacing
Regulation Description Hip joint femoral (hemi-hip) metallic resurfacing prosthesis.
Product CodeKXA
Regulation Number 888.3400
Device Class 2

Device Problems
Insufficient Information 1358
Adverse Event Without Identified Device or Use Problem 647
Appropriate Term/Code Not Available 482
Device Dislodged or Dislocated 259
Loss of Osseointegration 202
Naturally Worn 143
Noise, Audible 114
Corroded 92
Migration 73
Fracture 56
Metal Shedding Debris 55
Loss of or Failure to Bond 46
Osseointegration Problem 44
Degraded 36
Biocompatibility 24
Loose or Intermittent Connection 23
Malposition of device 23
Material Erosion 17
Use of Device Problem 16
Migration or Expulsion of Device 15
Unintended Movement 13
Material Disintegration 11
Break 9
Inadequacy of Device Shape and/or Size 8
Failure to Osseointegrate 7
Unstable 3
Patient Device Interaction Problem 3
Device Slipped 3
Mechanical Problem 2
Device Issue 2
Connection Problem 2
No Apparent Adverse Event 1
Disassembly 1
Explanted 1
Incorrect Measurement 1
Difficult or Delayed Separation 1
Expiration Date Error 1
Bent 1
Loosening of Implant Not Related to Bone-Ingrowth 1
Positioning Failure 1
Excess Flow or Over-Infusion 1
Incomplete or Missing Packaging 1
Device-Device Incompatibility 1
Device Contamination with Chemical or Other Material 1
Socket 1
Device Expiration Issue 1
Microbial Contamination of Device 1
Packaging Problem 1
Difficult to Insert 1
Ambient Noise Problem 1
Total Device Problems 3807


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