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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 component, cemented, metal
Regulation Description Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
Product CodeJDG
Regulation Number 888.3360
Device Class 2


Premarket Reviews
ManufacturerDecision
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Insufficient Information 772
Adverse Event Without Identified Device or Use Problem 202
Appropriate Term/Code Not Available 166
Break 151
Device Dislodged or Dislocated 145
Loss of Osseointegration 70
Fracture 53
Corroded 53
Naturally Worn 46
Unstable 37
Noise, Audible 33
Migration or Expulsion of Device 33
Material Erosion 21
Malposition of device 18
Degraded 17
Loss of or Failure to Bond 17
Metal Shedding Debris 16
Biocompatibility 15
Connection Problem 13
Material Twisted / Bent 13
Migration 12
Material Deformation 9
Loosening of Implant Not Related to Bone-Ingrowth 7
Mechanical Problem 7
Osseointegration Problem 7
Positioning Problem 6
Failure To Adhere Or Bond 5
Defective Device 5
Detachment of Device or device Component 5
Defective Component 4
Loose or Intermittent Connection 4
Material Integrity Problem 4
Unintended Movement 3
Material Disintegration 3
Flaked 3
Difficult to Insert 3
Material Fragmentation 2
Incomplete Coaptation 2
Failure to Align 2
Activation, Positioning or Separation Problem 2
No Apparent Adverse Event 2
Separation Failure 2
Device Handling Problem 2
Compatibility Problem 2
Use of Device Problem 2
Crack 2
Material Separation 2
Inadequacy of Device Shape and/or Size 2
Mechanical Jam 1
Fitting Problem 1
Tear, Rip or Hole in Device Packaging 1
Misconnection 1
Deformation Due to Compressive Stress 1
Device Contamination with Chemical or Other Material 1
Failure to Osseointegrate 1
Misassembled 1
Component Incompatible 1
Disassembly 1
Device Fell 1
Nonstandard device 1
Difficult to Remove 1
Solder Joint Fracture 1
Physical Resistance / Sticking 1
Total Device Problems 2017


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