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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 468 468
2020 533 533
2021 348 348

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1289 1289
Appropriate Term/Code Not Available 863 863
Insufficient Information 620 620
Patient Device Interaction Problem 425 425
Patient-Device Incompatibility 122 122
Metal Shedding Debris 117 117
Compatibility Problem 81 81
Loose or Intermittent Connection 73 73
Biocompatibility 59 59
Fracture 53 53
Break 53 53
Noise, Audible 51 51
Corroded 45 45
Device Operates Differently Than Expected 45 45
Device Dislodged or Dislocated 45 45
Material Fragmentation 41 41
Device Slipped 35 35
Naturally Worn 23 23
Loosening of Implant Not Related to Bone-Ingrowth 22 22
Degraded 18 18
Material Disintegration 17 17
Device Appears to Trigger Rejection 17 17
Unstable 16 16
Mechanical Problem 14 14
Malposition of Device 14 14
Unintended Movement 14 14
Therapeutic or Diagnostic Output Failure 9 9
Collapse 9 9
Migration or Expulsion of Device 8 8
Loss of Osseointegration 8 8
Pitted 6 6
Material Discolored 5 5
Inadequacy of Device Shape and/or Size 5 5
Improper or Incorrect Procedure or Method 5 5
Detachment of Device or Device Component 5 5
Material Integrity Problem 5 5
Material Twisted/Bent 5 5
Protective Measures Problem 5 5
Dull, Blunt 4 4
Defective Device 4 4
Detachment Of Device Component 4 4
Failure To Adhere Or Bond 4 4
Crack 3 3
Connection Problem 3 3
Device Contamination with Chemical or Other Material 3 3
Device-Device Incompatibility 2 2
Mechanics Altered 2 2
Positioning Problem 2 2
Structural Problem 2 2
Failure to Osseointegrate 2 2
Defective Component 2 2
Contamination 2 2
Material Erosion 2 2
Incorrect Measurement 2 2
Use of Device Problem 2 2
Nonstandard Device 2 2
Difficult to Remove 2 2
Migration 2 2
Physical Resistance/Sticking 1 1
No Apparent Adverse Event 1 1
Unstable Capture Threshold 1 1
Incorrect, Inadequate or Imprecise Resultor Readings 1 1
Material Too Rigid or Stiff 1 1
Material Separation 1 1
Unintended Collision 1 1
Sticking 1 1
Premature Elective Replacement Indicator 1 1
Off-Label Use 1 1
Difficult or Delayed Positioning 1 1
Loss of or Failure to Bond 1 1
Component Missing 1 1
Inaccurate Delivery 1 1
High Test Results 1 1
Suction Problem 1 1
Failure to Align 1 1
Failure to Advance 1 1
Failure to Cut 1 1
Contamination /Decontamination Problem 1 1
Material Protrusion/Extrusion 1 1
Material Deformation 1 1
Improper Chemical Reaction 1 1
Device Markings/Labelling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 1200 1201
Toxicity 841 843
Injury 770 770
Failure of Implant 698 698
No Code Available 519 520
Metal Related Pathology 387 387
Test Result 360 361
No Known Impact Or Consequence To Patient 131 131
Osteolysis 129 129
Reaction 128 128
Swelling 112 112
Loss of Range of Motion 111 111
No Information 102 102
Unspecified Infection 97 97
Inflammation 77 77
Ambulation Difficulties 76 76
Necrosis 74 74
Limited Mobility Of The Implanted Joint 61 61
Discomfort 58 58
Bone Fracture(s) 56 57
Debris, Bone Shedding 54 54
Tissue Damage 47 47
No Clinical Signs, Symptoms or Conditions 47 47
Joint Dislocation 44 44
Cyst(s) 39 39
Arthralgia 31 31
Synovitis 29 29
Foreign Body Reaction 27 27
Hip Fracture 26 26
Infiltration into Tissue 24 24
Complaint, Ill-Defined 17 17
Weakness 17 17
Hypersensitivity/Allergic reaction 16 16
Neuralgia 15 15
Ossification 15 15
Joint Laxity 14 14
Memory Loss/Impairment 14 14
Insufficient Information 13 13
Patient Problem/Medical Problem 13 14
Solid Tumour 12 12
Foreign Body In Patient 12 12
Fall 12 12
Fatigue 11 11
Host-Tissue Reaction 10 10
Local Reaction 10 10
Unspecified Tissue Injury 10 10
Swelling/ Edema 9 9
Muscle Weakness 9 9
Rash 9 9
Hearing Impairment 8 8
Hematoma 8 8
Sleep Dysfunction 8 8
Ankylosis 8 8
Muscular Rigidity 8 8
Tinnitus 8 8
Tissue Breakdown 7 7
Joint Swelling 7 7
Bacterial Infection 7 7
Death 7 7
Fluid Discharge 7 7
Emotional Changes 7 7
Sepsis 6 6
Numbness 6 6
Nerve Damage 6 6
Device Embedded In Tissue or Plaque 6 6
Post Operative Wound Infection 5 5
Shaking/Tremors 5 5
Osteopenia/ Osteoporosis 5 5
Partial Hearing Loss 5 5
Encephalopathy 5 5
Fever 5 5
Anemia 4 4
Cardiomyopathy 4 4
No Consequences Or Impact To Patient 4 4
Confusion/ Disorientation 4 4
Irritability 4 4
Tingling 4 4
Edema 4 4
Granuloma 4 4
Headache 4 4
Purulent Discharge 3 3
Scar Tissue 3 3
Seroma 3 3
Necrosis Of Flap Tissue 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
Thrombosis/Thrombus 3 3
Lymphoma 3 3
Muscle/Tendon Damage 3 3
Aspiration/Inhalation 3 3
Erosion 3 3
Erythema 3 3
High Blood Pressure/ Hypertension 3 3
Neuropathy 2 2
Hyperplasia 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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