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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
Product CodeKWI
Regulation Number 888.3170
Device Class 2


Premarket Reviews
ManufacturerDecision
DEPUY SYNTHES
  SUBSTANTIALLY EQUIVALENT 1
IGNITE ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
IN2BONES USA, LLC
  SUBSTANTIALLY EQUIVALENT 2
SKELETAL DYNAMICS, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 360 360
2018 202 202
2019 214 214
2020 118 118
2021 44 44
2022 21 53

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 201 213
Unintended Movement 148 148
Insufficient Information 92 92
Device Slipped 79 79
Loose or Intermittent Connection 75 84
Device Dislodged or Dislocated 57 66
Appropriate Term/Code Not Available 50 50
Detachment of Device or Device Component 44 44
Detachment Of Device Component 40 40
Loosening of Implant Not Related to Bone-Ingrowth 40 40
Migration or Expulsion of Device 34 34
Material Separation 33 33
Migration 19 21
Device Operates Differently Than Expected 15 15
Break 13 13
Mechanical Problem 13 13
Inadequacy of Device Shape and/or Size 12 12
Unstable 12 12
Nonstandard Device 10 10
Disassembly 8 8
Failure To Adhere Or Bond 8 8
Patient-Device Incompatibility 8 8
Fracture 7 7
Naturally Worn 7 7
Noise, Audible 6 6
Component Missing 6 6
Loss of Osseointegration 5 5
Failure to Osseointegrate 4 4
Fitting Problem 3 3
Material Deformation 2 2
Material Integrity Problem 2 2
Use of Device Problem 2 2
Physical Resistance/Sticking 2 2
Packaging Problem 2 2
Positioning Problem 2 2
Inaccurate Information 1 1
Difficult to Remove 1 1
Material Too Rigid or Stiff 1 1
Misconnection 1 1
Moisture Damage 1 1
Difficult to Insert 1 1
Loss of or Failure to Bond 1 1
Crack 1 1
Positioning Failure 1 1
Human Factors Issue 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Connection Problem 1 1
Delamination 1 1
Device Operational Issue 1 1
Improper or Incorrect Procedure or Method 1 1
Defective Device 1 1
Malposition of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 304 304
No Code Available 274 274
Failure of Implant 172 172
No Known Impact Or Consequence To Patient 111 111
Loss of Range of Motion 81 81
No Information 80 80
Osteolysis 45 45
Injury 36 36
Ossification 35 35
Bone Fracture(s) 24 26
Insufficient Information 20 48
Unspecified Infection 18 20
Limited Mobility Of The Implanted Joint 15 15
Joint Dislocation 13 13
Discomfort 13 13
Weakness 12 12
Nerve Damage 11 11
Tissue Damage 10 10
Arthritis 10 10
Muscular Rigidity 9 9
Swelling 8 8
Patient Problem/Medical Problem 8 8
Impaired Healing 5 5
Hypoesthesia 5 5
Non-union Bone Fracture 5 5
Fall 5 5
Fatigue 4 4
Inflammation 4 4
Scar Tissue 4 4
Ambulation Difficulties 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
No Clinical Signs, Symptoms or Conditions 4 4
Implant Pain 3 3
Joint Disorder 3 3
No Consequences Or Impact To Patient 3 3
Fracture, Arm 3 3
Bacterial Infection 3 3
Cyst(s) 3 3
Death 3 3
Erythema 2 2
Calcium Deposits/Calcification 2 2
Failure to Anastomose 2 2
Wound Dehiscence 2 2
Muscle Weakness 2 2
Hypersensitivity/Allergic reaction 2 2
Seroma 2 2
Synovitis 2 2
Neurological Deficit/Dysfunction 2 2
Neuropathy 2 2
Reaction 2 2
Numbness 2 2
Therapeutic Response, Decreased 2 2
Foreign Body In Patient 2 2
Inadequate Osseointegration 2 2
Osteopenia/ Osteoporosis 2 2
Muscle/Tendon Damage 2 2
Bone Shedding Debris 2 2
Unspecified Tissue Injury 1 1
Joint Laxity 1 1
Not Applicable 1 1
No Patient Involvement 1 1
Neck Stiffness 1 1
Sedation 1 1
Complaint, Ill-Defined 1 1
Rupture 1 1
Foreign Body Reaction 1 1
Adhesion(s) 1 1

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 May-12-2022
4 Synthes (USA) Products LLC II Feb-02-2017
5 Wright Medical Technology Inc II Sep-21-2020
6 Wright Medical Technology, Inc. II Feb-06-2020
7 Zimmer Biomet, Inc. II Dec-20-2017
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