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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)
2018 2019 2020 2021 2022 2023
2 0 1 0 1 1

MDR Year MDR Reports MDR Events
2018 579 579
2019 468 468
2020 533 533
2021 534 534
2022 429 429
2023 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1162 1162
Appropriate Term/Code Not Available 528 528
Biocompatibility 521 521
Patient Device Interaction Problem 415 415
Insufficient Information 369 369
Compatibility Problem 83 83
Break 78 78
Loose or Intermittent Connection 58 58
Patient-Device Incompatibility 51 51
Fracture 48 48
Corroded 40 40
Metal Shedding Debris 40 40
Material Fragmentation 38 38
Noise, Audible 38 38
Loosening of Implant Not Related to Bone-Ingrowth 37 37
Device Dislodged or Dislocated 36 36
Device Appears to Trigger Rejection 26 26
Material Disintegration 19 19
Degraded 19 19
Naturally Worn 19 19
Migration 18 18
Device Slipped 16 16
Loss of Osseointegration 14 14
Malposition of Device 13 13
Unstable 12 12
Unintended Movement 11 11
Mechanical Problem 10 10
Therapeutic or Diagnostic Output Failure 8 8
Device Operates Differently Than Expected 7 7
Detachment of Device or Device Component 6 6
Material Twisted/Bent 6 6
Pitted 6 6
Migration or Expulsion of Device 5 5
Collapse 5 5
Protective Measures Problem 5 5
Defective Device 5 5
Dull, Blunt 4 4
Material Integrity Problem 4 4
Material Discolored 4 4
Inadequacy of Device Shape and/or Size 4 4
Improper or Incorrect Procedure or Method 4 4
Use of Device Problem 3 3
Material Erosion 3 3
Crack 3 3
Mechanics Altered 3 3
Osseointegration Problem 3 3
No Apparent Adverse Event 3 3
Connection Problem 3 3
Structural Problem 2 2
Detachment Of Device Component 2 2
Contamination 2 2
Failure to Osseointegrate 2 2
Material Separation 2 2
Difficult to Remove 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Unintended Collision 1 1
Premature Elective Replacement Indicator 1 1
Off-Label Use 1 1
Suction Problem 1 1
Defective Component 1 1
Component Missing 1 1
Inaccurate Delivery 1 1
Positioning Failure 1 1
Loss of or Failure to Bond 1 1
Incorrect Measurement 1 1
Failure to Align 1 1
Failure to Cut 1 1
High Test Results 1 1
Device Contamination with Chemical or Other Material 1 1
Device Markings/Labelling Problem 1 1
Contamination /Decontamination Problem 1 1
Unstable Capture Threshold 1 1
Positioning Problem 1 1
Material Protrusion/Extrusion 1 1
Material Deformation 1 1
Component Misassembled 1 1
Physical Resistance/Sticking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 1070 1071
Metal Related Pathology 839 839
Injury 722 722
Toxicity 554 556
Failure of Implant 397 397
Test Result 326 327
No Code Available 278 279
Loss of Range of Motion 148 148
Osteolysis 146 146
Infiltration into Tissue 118 118
Unspecified Infection 99 99
Ambulation Difficulties 95 95
No Known Impact Or Consequence To Patient 84 84
No Clinical Signs, Symptoms or Conditions 82 82
Discomfort 75 75
No Information 74 74
Inflammation 74 74
Bone Fracture(s) 69 70
Reaction 66 66
Swelling 60 60
Necrosis 58 58
Limited Mobility Of The Implanted Joint 55 55
Joint Dislocation 54 54
Cyst(s) 54 54
Insufficient Information 53 53
Arthralgia 52 52
Debris, Bone Shedding 51 51
Hip Fracture 42 42
Tissue Damage 38 38
Synovitis 36 36
Foreign Body Reaction 34 34
Inadequate Osseointegration 26 26
Unequal Limb Length 23 23
Joint Laxity 23 23
Solid Tumour 22 22
Swelling/ Edema 21 21
Ossification 19 19
Unspecified Tissue Injury 15 15
Neuralgia 15 15
Memory Loss/Impairment 14 14
Deformity/ Disfigurement 14 14
Osteopenia/ Osteoporosis 13 13
Bacterial Infection 13 13
Fall 13 13
Hematoma 12 12
Hypersensitivity/Allergic reaction 12 12
Weakness 11 11
Tissue Breakdown 10 10
Patient Problem/Medical Problem 10 11
Muscular Rigidity 10 10
Fatigue 10 10
Host-Tissue Reaction 9 9
Muscle Weakness 9 9
Sepsis 8 8
Cardiomyopathy 8 8
Hearing Impairment 8 8
Foreign Body In Patient 8 8
Sleep Dysfunction 8 8
Ankylosis 8 8
Muscle/Tendon Damage 7 7
Local Reaction 7 7
Nerve Damage 6 6
Headache 6 6
Post Operative Wound Infection 6 6
Weight Changes 5 5
Joint Swelling 5 5
Complaint, Ill-Defined 5 5
Rash 5 5
Fever 5 5
Encephalopathy 5 5
Erosion 5 5
Death 5 5
Partial Hearing Loss 5 5
Embolism/Embolus 4 4
Anemia 4 4
Emotional Changes 4 4
Granuloma 4 4
Seroma 4 4
Tinnitus 4 4
Anxiety 4 4
No Consequences Or Impact To Patient 4 4
Tingling 4 4
Confusion/ Disorientation 4 4
Fibrosis 4 4
Irritability 4 4
Shaking/Tremors 4 4
Numbness 4 4
Cognitive Changes 3 3
Fluid Discharge 3 3
Dizziness 3 3
Blurred Vision 3 3
Depression 3 3
Hyperplasia 3 3
Necrosis Of Flap Tissue 3 3
Erythema 3 3
Aspiration/Inhalation 3 3
Thrombosis/Thrombus 3 3
Renal Impairment 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Implant Pain 2 2

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