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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 1367
Adverse Event Without Identified Device or Use Problem 794
Appropriate Term/Code Not Available 480
Device Dislodged or Dislocated 283
Loss of Osseointegration 211
Naturally Worn 164
Migration 153
Noise, Audible 120
Corroded 106
Fracture 62
Metal Shedding Debris 55
Loss of or Failure to Bond 54
Osseointegration Problem 48
Degraded 47
Malposition of device 28
Use of Device Problem 26
Biocompatibility 24
Loose or Intermittent Connection 23
Material Erosion 20
Unintended Movement 17
Migration or Expulsion of Device 16
Material Disintegration 14
Inadequacy of Device Shape and/or Size 14
Break 13
Failure to Osseointegrate 7
Loosening of Implant Not Related to Bone-Ingrowth 4
Patient Device Interaction Problem 3
Mechanical Problem 3
Device Slipped 3
Unstable 3
Device-Device Incompatibility 2
Difficult to Insert 2
Off-Label Use 2
Physical Resistance / Sticking 2
Expiration Date Error 2
Connection Problem 2
Entrapment of Device 2
Packaging Problem 2
Device Issue 2
Illegible Information 2
Bent 1
Incorrect Measurement 1
Disassembly 1
Socket 1
Ambient Noise Problem 1
Mechanical Jam 1
Excess Flow or Over-Infusion 1
Material Separation 1
Microbial Contamination of Device 1
Tear, Rip or Hole in Device Packaging 1
Device Contamination with Chemical or Other Material 1
Device Contaminated during manufacture or shipping 1
Device Expiration Issue 1
Explanted 1
Difficult or Delayed Separation 1
No Apparent Adverse Event 1
Incomplete or Missing Packaging 1
Scratched Material 1
Total Device Problems 4200


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