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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
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 42 74

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 205 217
Unintended Movement 148 148
Insufficient Information 92 92
Device Slipped 79 79
Loose or Intermittent Connection 75 84
Device Dislodged or Dislocated 58 67
Detachment of Device or Device Component 51 51
Appropriate Term/Code Not Available 50 50
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 21 23
Device Operates Differently Than Expected 15 15
Break 14 14
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
Fracture 8 8
Patient-Device Incompatibility 8 8
Naturally Worn 7 7
Component Missing 6 6
Noise, Audible 6 6
Loss of Osseointegration 5 5
Failure to Osseointegrate 4 4
Inaccurate Information 3 3
Fitting Problem 3 3
Material Deformation 2 2
Material Integrity Problem 2 2
Physical Resistance/Sticking 2 2
Misassembly by Users 2 2
Packaging Problem 2 2
Use of Device Problem 2 2
Positioning Problem 2 2
Difficult to Insert 1 1
Moisture Damage 1 1
Malposition of Device 1 1
Connection Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Loss of or Failure to Bond 1 1
Crack 1 1
Defective Device 1 1
Delamination 1 1
Patient Device Interaction Problem 1 1
Device Operational Issue 1 1
Human Factors Issue 1 1
Positioning Failure 1 1
Difficult to Remove 1 1
Material Too Rigid or Stiff 1 1
Improper or Incorrect Procedure or Method 1 1
Misconnection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 307 307
No Code Available 274 274
Failure of Implant 177 177
No Known Impact Or Consequence To Patient 111 111
Loss of Range of Motion 84 84
No Information 80 80
Osteolysis 45 45
Injury 36 36
Ossification 35 35
Insufficient Information 26 54
Bone Fracture(s) 24 26
Unspecified Infection 18 20
Limited Mobility Of The Implanted Joint 15 15
Joint Dislocation 14 14
Discomfort 13 13
Weakness 12 12
Nerve Damage 11 11
Tissue Damage 10 10
Arthritis 10 10
Muscular Rigidity 9 9
No Clinical Signs, Symptoms or Conditions 9 9
Patient Problem/Medical Problem 8 8
Swelling 8 8
Hypoesthesia 5 5
Fall 5 5
Bacterial Infection 5 5
Non-union Bone Fracture 5 5
Impaired Healing 5 5
Scar Tissue 4 4
Ambulation Difficulties 4 4
Fatigue 4 4
Inflammation 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Cyst(s) 3 3
Joint Disorder 3 3
Death 3 3
Unspecified Tissue Injury 3 3
Implant Pain 3 3
Fracture, Arm 3 3
No Consequences Or Impact To Patient 3 3
Muscle Weakness 2 2
Neuropathy 2 2
Wound Dehiscence 2 2
Calcium Deposits/Calcification 2 2
Erythema 2 2
Osteopenia/ Osteoporosis 2 2
Numbness 2 2
Muscle/Tendon Damage 2 2
Bone Shedding Debris 2 2
Synovitis 2 2
Reaction 2 2
Inadequate Osseointegration 2 2
Seroma 2 2
Foreign Body In Patient 2 2
Therapeutic Response, Decreased 2 2
Joint Laxity 2 2
Hypersensitivity/Allergic reaction 2 2
Failure to Anastomose 2 2
Neurological Deficit/Dysfunction 2 2
Neck Stiffness 1 1
Sedation 1 1
Not Applicable 1 1
Foreign Body Reaction 1 1
Myalgia 1 1
Swelling/ Edema 1 1
No Patient Involvement 1 1
Complaint, Ill-Defined 1 1
Adhesion(s) 1 1
Rupture 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 Oct-04-2022
7 Wright Medical Technology, Inc. II Feb-06-2020
8 Zimmer Biomet, Inc. II Dec-20-2017
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