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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/metal, resurfacing
Definition Prosthesis, hip, semi-constrained, metal/metal, resurfacing device relieves hip pain and improves hip function by replacing the parts of the hip that have been severely damaged by degenerative joint diseases. This device is indicated for patients with degenerative joint diseases including osteoarthritis, rheumatoid arthritis, traumatic arthritis, dysplasia, or avascular necrosis and for patients who, due to their relatively younger age or increased activity level, may not be suitable for traditional total hip replacement due to an increased possibility of requiring future hip joint revision.
Product CodeNXT
Device Class 3

Premarket Approvals (PMA)
2016 2017 2018 2019 2020 2021
3 1 2 0 1 0

MDR Year MDR Reports MDR Events
2016 358 358
2017 460 460
2018 579 579
2019 469 469
2020 538 538

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1023 1023
Appropriate Term/Code Not Available 863 863
Insufficient Information 617 617
Patient Device Interaction Problem 425 425
Patient-Device Incompatibility 120 120
Metal Shedding Debris 117 117
Loose or Intermittent Connection 71 71
Compatibility Problem 67 67
Fracture 52 52
Noise, Audible 51 51
Device Operates Differently Than Expected 45 45
Device Dislodged or Dislocated 45 45
Material Fragmentation 41 41
Corroded 40 40
Break 36 36
Device Slipped 35 35
Naturally Worn 22 22
Degraded 18 18
Loosening of Implant Not Related to Bone-Ingrowth 18 18
Material Disintegration 17 17
Unstable 16 16
Unintended Movement 14 14
Mechanical Problem 14 14
Malposition of Device 13 13
Collapse 9 9
Therapeutic or Diagnostic Output Failure 9 9
Migration or Expulsion of Device 8 8
Pitted 6 6
Protective Measures Problem 5 5
Detachment of Device or Device Component 5 5
Loss of Osseointegration 5 5
Improper or Incorrect Procedure or Method 5 5
Inadequacy of Device Shape and/or Size 5 5
Material Discolored 5 5
Material Integrity Problem 5 5
Dull, Blunt 4 4
Failure To Adhere Or Bond 4 4
Detachment Of Device Component 4 4
Defective Device 4 4
Crack 3 3
Device Contamination with Chemical or Other Material 3 3
Mechanics Altered 2 2
Device-Device Incompatibility 2 2
Connection Problem 2 2
Cannula 2 2
Positioning Problem 2 2
Migration 2 2
Contamination 2 2
Material Erosion 2 2
Defective Component 2 2
Nonstandard Device 2 2
Incorrect Measurement 2 2
Difficult to Remove 2 2
Structural Problem 2 2
Use of Device Problem 2 2
Failure to Osseointegrate 2 2
Suction Problem 1 1
Inaccurate Delivery 1 1
Off-Label Use 1 1
Failure to Align 1 1
Failure to Cut 1 1
Material Protrusion/Extrusion 1 1
Incorrect, Inadequate or Imprecise Resultor Readings 1 1
Material Too Rigid or Stiff 1 1
Material Separation 1 1
Screw 1 1
Cup 1 1
Heads 1 1
Socket 1 1
Loss of or Failure to Bond 1 1
Tip 1 1
No Apparent Adverse Event 1 1
Sticking 1 1
High Test Results 1 1
Failure to Advance 1 1
Contamination /Decontamination Problem 1 1
Unintended Collision 1 1
Device Appears to Trigger Rejection 1 1
Difficult or Delayed Positioning 1 1
Physical Resistance/Sticking 1 1
Unstable Capture Threshold 1 1
Device Markings/Labelling Problem 1 1
Improper Chemical Reaction 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 1035 1036
Toxicity 842 844
Injury 769 769
Failure of Implant 618 618
No Code Available 519 520
Test Result 361 362
No Known Impact Or Consequence To Patient 131 131
Reaction 128 128
Metal Related Pathology 120 120
Swelling 113 113
No Information 98 98
Osteolysis 97 97
Unspecified Infection 85 85
Necrosis 69 69
Ambulation Difficulties 66 66
Inflammation 65 65
Limited Mobility Of The Implanted Joint 62 62
Loss of Range of Motion 60 60
Discomfort 54 54
Debris, Bone Shedding 54 54
Bone Fracture(s) 51 52
Tissue Damage 47 47
Joint Dislocation 34 34
Cyst(s) 27 27
Synovitis 24 24
Foreign Body Reaction 20 20
Hip Fracture 20 20
Arthralgia 18 18
Complaint, Ill-Defined 17 17
Weakness 17 17
Hypersensitivity/Allergic reaction 16 16
Memory Loss/Impairment 14 14
Patient Problem/Medical Problem 13 14
Foreign Body In Patient 12 12
Ossification 12 12
Fall 12 12
No Clinical Signs, Symptoms or Conditions 12 12
Host-Tissue Reaction 10 10
Local Reaction 10 10
Rash 9 9
Insufficient Information 9 9
Tinnitus 8 8
Joint Swelling 7 7
Muscular Rigidity 7 7
Bacterial Infection 7 7
Death 7 7
Hematoma 7 7
Fatigue 7 7
Emotional Changes 7 7
Sleep Dysfunction 6 6
Numbness 6 6
Device Embedded In Tissue or Plaque 6 6
Shaking/Tremors 5 5
Fluid Discharge 5 5
Encephalopathy 5 5
Cardiomyopathy 4 4
No Consequences Or Impact To Patient 4 4
Confusion/ Disorientation 4 4
Irritability 4 4
Tingling 4 4
Headache 4 4
Edema 4 4
Purulent Discharge 3 3
Necrosis Of Flap Tissue 3 3
Seroma 3 3
Blurred Vision 3 3
Visual Impairment 3 3
Loss of Vision 3 3
Depression 3 3
Joint Disorder 3 3
Skin Discoloration 3 4
Cognitive Changes 3 3
Osteopenia/ Osteoporosis 3 3
Lymphoma 3 3
Aspiration/Inhalation 3 3
Erosion 3 3
High Blood Pressure/ Hypertension 3 3
Muscle Weakness 3 3
Sepsis 3 3
Neuropathy 2 2
Fever 2 2
Hearing Impairment 2 2
Hearing Loss 2 2
Abscess 2 2
Congestive Heart Failure 2 2
Neuralgia 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Collapse 2 2
Vertigo 2 2
Vomiting 2 2
Tissue Breakdown 2 2
Weight Changes 2 2
No Patient Involvement 2 2
Fibrosis 2 2
Pleural Effusion 2 2
Thyroid Problems 2 2
Nausea 2 2
Granuloma 2 2
Hair Loss 2 2
Atrial Fibrillation 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Smith & Nephew, Inc. II May-21-2018
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