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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)
2019 2020 2021 2022 2023 2024
0 1 0 1 1 1

MDR Year MDR Reports MDR Events
2019 467 467
2020 533 533
2021 528 528
2022 426 426
2023 143 143
2024 41 41

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 954 954
Biocompatibility 665 665
Appropriate Term/Code Not Available 317 317
Patient Device Interaction Problem 310 310
Insufficient Information 131 131
Compatibility Problem 83 83
Break 72 72
Loosening of Implant Not Related to Bone-Ingrowth 51 51
Fracture 38 38
Loose or Intermittent Connection 38 38
Corroded 34 34
Noise, Audible 30 30
Migration 28 28
Device Appears to Trigger Rejection 27 27
Material Fragmentation 26 26
Device Dislodged or Dislocated 25 25
Patient-Device Incompatibility 20 20
Loss of Osseointegration 20 20
Naturally Worn 19 19
Degraded 18 18
Malposition of Device 13 13
Device Slipped 9 9
Unstable 8 8
Material Disintegration 8 8
Mechanical Problem 8 8
Therapeutic or Diagnostic Output Failure 8 8
Material Twisted/Bent 6 6
Defective Device 5 5
No Apparent Adverse Event 4 4
Collapse 4 4
Pitted 4 4
Inadequacy of Device Shape and/or Size 4 4
Dull, Blunt 4 4
Improper or Incorrect Procedure or Method 3 3
Crack 3 3
Material Erosion 3 3
Detachment of Device or Device Component 3 3
Osseointegration Problem 3 3
Connection Problem 2 2
Unintended Movement 2 2
Migration or Expulsion of Device 2 2
Material Discolored 2 2
Material Separation 2 2
Use of Device Problem 2 2
Failure to Osseointegrate 2 2
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Suction Problem 1 1
Defective Component 1 1
Component Missing 1 1
Inaccurate Delivery 1 1
Failure to Align 1 1
Failure to Cut 1 1
Loss of or Failure to Bond 1 1
Positioning Failure 1 1
Contamination 1 1
Incorrect Measurement 1 1
Unstable Capture Threshold 1 1
Component Misassembled 1 1
Physical Resistance/Sticking 1 1
Device Markings/Labelling Problem 1 1
Contamination /Decontamination Problem 1 1
Positioning Problem 1 1
Protective Measures Problem 1 1
Mechanics Altered 1 1
Material Deformation 1 1
Material Protrusion/Extrusion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Metal Related Pathology 911 911
Pain 868 868
Injury 472 472
Toxicity 325 326
Failure of Implant 305 305
Test Result 176 176
Loss of Range of Motion 147 147
Osteolysis 132 132
Infiltration into Tissue 123 123
No Code Available 93 93
No Clinical Signs, Symptoms or Conditions 90 90
Unspecified Infection 89 89
Ambulation Difficulties 79 79
Discomfort 79 79
Arthralgia 71 71
Insufficient Information 71 71
Inflammation 60 60
Cyst(s) 57 57
Bone Fracture(s) 55 55
No Known Impact Or Consequence To Patient 54 54
Necrosis 49 49
Joint Dislocation 48 48
Hip Fracture 43 43
Limited Mobility Of The Implanted Joint 43 43
Inadequate Osseointegration 41 41
Synovitis 41 41
Swelling 35 35
Foreign Body Reaction 34 34
Reaction 33 33
Implant Pain 31 31
Joint Laxity 28 28
Unequal Limb Length 27 27
Debris, Bone Shedding 27 27
No Information 26 26
Solid Tumour 23 23
Swelling/ Edema 22 22
Tissue Damage 20 20
Ossification 19 19
Deformity/ Disfigurement 18 18
Unspecified Tissue Injury 16 16
Neuralgia 15 15
Bacterial Infection 14 14
Osteopenia/ Osteoporosis 13 13
Fall 12 12
Memory Loss/Impairment 12 12
Fatigue 10 10
Hematoma 9 9
Muscle Weakness 9 9
Tissue Breakdown 9 9
Muscular Rigidity 8 8
Sepsis 8 8
Hearing Impairment 8 8
Cardiomyopathy 8 8
Muscle/Tendon Damage 8 8
Ankylosis 8 8
Local Reaction 7 7
Scar Tissue 7 7
Nerve Damage 7 7
Sleep Dysfunction 7 7
Numbness 7 7
Patient Problem/Medical Problem 6 6
Fibrosis 6 6
Post Operative Wound Infection 6 6
Host-Tissue Reaction 6 6
Headache 5 5
Encephalopathy 5 5
Partial Hearing Loss 5 5
Emotional Changes 4 4
Fever 4 4
Granuloma 4 4
Anemia 4 4
Hypersensitivity/Allergic reaction 4 4
Shaking/Tremors 4 4
Irritability 4 4
Fluid Discharge 4 4
Confusion/ Disorientation 4 4
Weight Changes 4 4
Unspecified Mental, Emotional or Behavioural Problem 4 4
Embolism/Embolus 4 4
Anxiety 4 4
Tinnitus 4 4
Weakness 4 4
No Consequences Or Impact To Patient 4 4
Tingling 3 3
Dizziness 3 3
Blurred Vision 3 3
Thrombosis/Thrombus 3 3
Cognitive Changes 3 3
Hyperplasia 3 3
Erosion 3 3
Erythema 3 3
Renal Impairment 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Total Hearing Loss 2 2
Malunion of Bone 2 2
Subluxation 2 2
Purulent Discharge 2 2
Hearing Loss 2 2
Chest Pain 2 2
Congestive Heart Failure 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Smith & Nephew Orthopaedics Ltd. (Aurora) II Aug-11-2021
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