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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, hip, semi-constrained (metal cemented acetabular component)
Product CodeJDL
Regulation Number 888.3320
Device Class 3

MDR Year MDR Reports MDR Events
2014 515 515
2015 466 466
2016 299 299
2017 336 336
2018 206 206
2019 140 140
2020 94 94
2021 68 68
2022 49 49
2023 33 33
2024 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 1242 1242
Metal Shedding Debris 158 158
Device Dislodged or Dislocated 130 130
Corroded 127 127
Adverse Event Without Identified Device or Use Problem 110 110
Appropriate Term/Code Not Available 97 97
Loose or Intermittent Connection 66 66
Naturally Worn 60 60
Material Disintegration 52 52
Noise, Audible 45 45
Break 41 41
Device Operates Differently Than Expected 40 40
Fracture 31 31
Unstable 28 28
Device Slipped 28 28
Patient-Device Incompatibility 24 24
Loss of Osseointegration 23 23
Material Erosion 22 22
Malposition of Device 21 21
Detachment of Device or Device Component 18 18
Migration or Expulsion of Device 15 15
Difficult to Remove 9 9
Compatibility Problem 9 9
Material Integrity Problem 8 8
Positioning Problem 7 7
Mechanical Problem 6 6
Material Frayed 6 6
Detachment Of Device Component 5 5
Inadequacy of Device Shape and/or Size 5 5
Difficult to Insert 4 4
Disassembly 4 4
Material Discolored 3 3
Material Fragmentation 3 3
Degraded 3 3
Fitting Problem 3 3
Patient Device Interaction Problem 3 3
Migration 3 3
Therapeutic or Diagnostic Output Failure 2 2
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Packaging Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Material Separation 2 2
Shipping Damage or Problem 1 1
Sticking 1 1
Unexpected Therapeutic Results 1 1
Defective Component 1 1
Poor Quality Image 1 1
Unintended Collision 1 1
Unsealed Device Packaging 1 1
Failure To Adhere Or Bond 1 1
Crack 1 1
Component Incompatible 1 1
Computer Software Problem 1 1
Gradient Increase 1 1
Disconnection 1 1
Failure to Deliver Energy 1 1
Improper Chemical Reaction 1 1
Material Deformation 1 1
Material Distortion 1 1
Material Twisted/Bent 1 1
Mechanics Altered 1 1
Device Markings/Labelling Problem 1 1
Device-Device Incompatibility 1 1
Dent in Material 1 1
Separation Failure 1 1
Delamination 1 1
Temperature Problem 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Reaction 874 874
Pain 680 680
No Information 265 265
No Code Available 223 223
Toxicity 184 184
Unspecified Infection 135 135
Metal Related Pathology 90 90
Tissue Damage 75 75
Osteolysis 66 66
Ambulation Difficulties 62 62
Test Result 56 56
Swelling 46 46
Limited Mobility Of The Implanted Joint 45 45
Complaint, Ill-Defined 37 37
No Known Impact Or Consequence To Patient 34 34
Inflammation 34 34
Joint Dislocation 33 33
Insufficient Information 30 30
Bone Fracture(s) 30 30
Failure of Implant 28 28
Loss of Range of Motion 27 27
Necrosis 24 24
Discomfort 23 23
Injury 18 18
Seroma 14 14
Host-Tissue Reaction 12 12
Fluid Discharge 11 11
Synovitis 10 10
Scar Tissue 7 7
Osteopenia/ Osteoporosis 7 7
Foreign Body Reaction 6 6
No Consequences Or Impact To Patient 5 5
Inadequate Osseointegration 5 5
Unequal Limb Length 4 4
Deformity/ Disfigurement 4 4
Disability 4 4
Hip Fracture 4 4
Fever 4 4
Hypersensitivity/Allergic reaction 4 4
Ossification 4 4
Cyst(s) 3 3
Death 3 3
Calcium Deposits/Calcification 3 3
Edema 3 3
Fall 3 3
Granuloma 3 3
Local Reaction 3 3
Dizziness 3 3
Sepsis 3 3
Nausea 3 3
Neuropathy 3 3
Unspecified Tissue Injury 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Fibrosis 3 3
Swelling/ Edema 2 2
Device Embedded In Tissue or Plaque 2 2
Sleep Dysfunction 2 2
Chemical Exposure 2 2
Neck Pain 2 2
Nerve Damage 2 2
Rash 2 2
Thrombus 2 2
Headache 2 2
Hearing Loss 2 2
Hematoma 2 2
Keratitis 2 2
Memory Loss/Impairment 2 2
Muscle Weakness 2 2
Emotional Changes 2 2
Wound Dehiscence 2 2
Dyspnea 2 2
Debris, Bone Shedding 2 2
Aspiration/Inhalation 2 2
Bacterial Infection 1 1
Adhesion(s) 1 1
Dementia 1 1
Purulent Discharge 1 1
Cardiac Arrest 1 1
Cellulitis 1 1
Fatigue 1 1
Muscular Rigidity 1 1
Iritis 1 1
Irritation 1 1
Low Blood Pressure/ Hypotension 1 1
Urinary Tract Infection 1 1
Vomiting 1 1
Weakness 1 1
Burning Sensation 1 1
Immunodeficiency 1 1
Cramp(s) 1 1
Arthralgia 1 1
Malaise 1 1
Joint Disorder 1 1
Tentorial Tears 1 1
Thrombosis 1 1
Device Overstimulation of Tissue 1 1
Pelvic Inflammatory Disease 1 1
Neck Stiffness 1 1
Prolapse 1 1
Numbness 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Wright Medical Technology Inc II Jun-25-2015
2 Wright Medical Technology Inc III Aug-12-2010
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