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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, elbow, hemi-, radial, polymer
Regulation Description Elbow joint radial (hemi-elbow) polymer prosthesis.
Product CodeKWI
Regulation Number 888.3170
Device Class 2


Premarket Reviews
ManufacturerDecision
IN2BONES USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
SKELETAL DYNAMICS, LLC
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Unintended Movement 194
Adverse Event Without Identified Device or Use Problem 117
Insufficient Information 72
Device Slipped 41
Migration or Expulsion of Device 41
Detachment of Device or device Component 23
Loose or Intermittent Connection 19
Loosening of Implant Not Related to Bone-Ingrowth 16
Detachment Of Device Component 13
Mechanical Problem 12
Migration 12
Device Dislodged or Dislocated 11
Break 11
Device Operates Differently Than Expected 9
Failure To Adhere Or Bond 8
Appropriate Term/Code Not Available 8
Unstable 6
Patient-Device Incompatibility 5
Fracture 5
Component Missing 5
Fitting Problem 4
Loss of Osseointegration 3
Naturally Worn 3
Malposition of device 3
Material Integrity Problem 3
Metal Shedding Debris 2
Screw 2
Loss of or Failure to Bond 2
Difficult to Insert 2
Material Separation 2
Device Issue 2
Material Fragmentation 1
Inadequacy of Device Shape and/or Size 1
Material Erosion 1
Material Rupture 1
Packaging Problem 1
Missing Value Reason 1
Disassembly 1
Misassembled 1
Connection Problem 1
Tear, Rip or Hole in Device Packaging 1
Material Disintegration 1
Difficult to Remove 1
Failure to Osseointegrate 1
Device Operational Issue 1
Total Device Problems 670

Recalls
Manufacturer Recall Class Date Posted
1 Acumed LLC II May-31-2017
2 Howmedica Osteonics Corp. II Aug-08-2018
3 Synthes (USA) Products LLC II Feb-02-2017
4 Wright Medical Technology, Inc. II Feb-06-2020
5 Zimmer Biomet, Inc. II Dec-20-2017

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