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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)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
9 4 7 1 1 5 2 3 1 2 0 1 0 1 1 1

MDR Year MDR Reports MDR Events
2014 700 700
2015 362 362
2016 358 358
2017 460 460
2018 578 578
2019 467 467
2020 533 533
2021 528 528
2022 426 426
2023 143 143
2024 39 39

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1560 1560
Insufficient Information 1141 1141
Appropriate Term/Code Not Available 1059 1059
Biocompatibility 666 666
Patient Device Interaction Problem 435 435
Metal Shedding Debris 197 197
Device Operates Differently Than Expected 150 150
Patient-Device Incompatibility 140 140
Break 91 91
Loose or Intermittent Connection 89 89
Fracture 84 84
Compatibility Problem 84 84
Noise, Audible 82 82
Device Dislodged or Dislocated 64 64
Device Slipped 53 53
Loosening of Implant Not Related to Bone-Ingrowth 52 52
Corroded 49 49
Material Fragmentation 42 42
Material Integrity Problem 41 41
Naturally Worn 37 37
Malposition of Device 31 31
Migration 29 29
Device Appears to Trigger Rejection 27 27
Mechanical Problem 24 24
Degraded 23 23
Loss of Osseointegration 22 22
Unstable 20 20
Material Disintegration 19 19
Unintended Movement 16 16
Migration or Expulsion of Device 11 11
Collapse 10 10
Therapeutic or Diagnostic Output Failure 9 9
Inadequacy of Device Shape and/or Size 8 8
Improper or Incorrect Procedure or Method 8 8
Detachment of Device or Device Component 6 6
Pitted 6 6
Material Twisted/Bent 6 6
Protective Measures Problem 5 5
No Apparent Adverse Event 5 5
Nonstandard Device 5 5
Crack 5 5
Material Discolored 5 5
Material Erosion 5 5
Defective Device 5 5
Connection Problem 4 4
Dull, Blunt 4 4
Failure To Adhere Or Bond 4 4
Detachment Of Device Component 4 4
Difficult to Remove 3 3
Component Missing 3 3
Use of Device Problem 3 3
Device Contamination with Chemical or Other Material 3 3
Device-Device Incompatibility 3 3
Positioning Problem 3 3
Osseointegration Problem 3 3
Mechanics Altered 3 3
Improper Chemical Reaction 2 2
High Test Results 2 2
Structural Problem 2 2
Failure to Align 2 2
Failure to Advance 2 2
Failure to Cut 2 2
Sticking 2 2
Failure to Osseointegrate 2 2
Defective Component 2 2
Material Separation 2 2
Incorrect Measurement 2 2
Contamination 2 2
Bent 1 1
Loss of or Failure to Bond 1 1
Difficult to Insert 1 1
Entrapment of Device 1 1
Difficult or Delayed Positioning 1 1
Positioning Failure 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Material Too Rigid or Stiff 1 1
Unintended Collision 1 1
Premature Elective Replacement Indicator 1 1
Premature explantation 1 1
Premature system activation 1 1
Off-Label Use 1 1
Incorrect Or Inadequate Test Results 1 1
Inaccurate Delivery 1 1
Device Issue 1 1
Device Inoperable 1 1
Suction Problem 1 1
Insufficient Flow or Under Infusion 1 1
Fitting Problem 1 1
Contamination /Decontamination Problem 1 1
Contamination of Device Ingredient or Reagent 1 1
Device Markings/Labelling Problem 1 1
No Fail-Safe Mechanism 1 1
Material Protrusion/Extrusion 1 1
Material Deformation 1 1
Packaging Problem 1 1
Component Misassembled 1 1
Physical Resistance/Sticking 1 1
Unstable Capture Threshold 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 1827 1828
Toxicity 1227 1229
Metal Related Pathology 910 910
No Code Available 868 869
Failure of Implant 839 839
Injury 786 786
Test Result 424 425
Osteolysis 210 210
Reaction 205 205
Swelling 168 168
Loss of Range of Motion 167 167
Weakness 153 153
No Known Impact Or Consequence To Patient 138 138
Unspecified Infection 137 137
Ambulation Difficulties 133 133
Infiltration into Tissue 124 124
Discomfort 123 123
No Information 119 119
Necrosis 105 105
Inflammation 99 99
Bone Fracture(s) 92 93
No Clinical Signs, Symptoms or Conditions 90 90
Arthralgia 76 76
Joint Swelling 73 73
Joint Dislocation 73 73
Insufficient Information 73 73
Cyst(s) 71 71
Limited Mobility Of The Implanted Joint 68 68
Tissue Damage 67 67
Muscle Weakness 63 63
Debris, Bone Shedding 54 54
Synovitis 53 53
Hip Fracture 51 51
Foreign Body Reaction 42 42
Inadequate Osseointegration 41 41
Complaint, Ill-Defined 40 40
Hypersensitivity/Allergic reaction 30 30
Implant Pain 30 30
Joint Laxity 28 28
Unequal Limb Length 27 27
Fall 27 27
Host-Tissue Reaction 25 25
Chemical Exposure 23 23
Solid Tumour 23 23
Swelling/ Edema 22 22
Ossification 22 22
Foreign Body In Patient 21 21
Fatigue 18 18
Rash 18 18
Deformity/ Disfigurement 18 18
Memory Loss/Impairment 17 17
Bacterial Infection 17 17
Unspecified Tissue Injury 16 16
Fluid Discharge 15 15
Neuralgia 15 15
Hematoma 14 14
Patient Problem/Medical Problem 13 14
Osteopenia/ Osteoporosis 13 13
Tissue Breakdown 12 12
Numbness 12 12
Muscular Rigidity 11 11
Local Reaction 11 11
Sleep Dysfunction 10 10
Seroma 10 10
Scar Tissue 9 9
Sepsis 9 9
Device Embedded In Tissue or Plaque 9 9
Ankylosis 8 8
Muscle/Tendon Damage 8 8
Tinnitus 8 8
Hearing Impairment 8 8
Cardiomyopathy 8 8
Edema 8 8
Emotional Changes 8 8
Death 7 7
Headache 7 7
Nerve Damage 7 7
Weight Changes 7 7
Fibrosis 6 6
Erosion 6 6
Shaking/Tremors 6 6
Post Operative Wound Infection 6 6
Depression 6 6
Confusion/ Disorientation 5 5
Skin Discoloration 5 6
Tingling 5 5
Dizziness 5 5
No Consequences Or Impact To Patient 5 5
Encephalopathy 5 5
Hearing Loss 5 5
Partial Hearing Loss 5 5
Unspecified Mental, Emotional or Behavioural Problem 4 4
Embolism/Embolus 4 4
High Blood Pressure/ Hypertension 4 4
Hyperplasia 4 4
Erythema 4 4
Granuloma 4 4
Fever 4 4
Anemia 4 4
Loss of Vision 4 4

Recalls
Manufacturer Recall Class Date Posted
1 Smith & Nephew Orthopaedics Ltd. (Aurora) II Aug-11-2021
2 Smith & Nephew, Inc. II May-21-2018
3 Smith & Nephew, Inc. II Sep-10-2015
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