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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 131 131

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1600 1600
Insufficient Information 1141 1141
Appropriate Term/Code Not Available 1059 1059
Biocompatibility 719 719
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 86 86
Compatibility Problem 84 84
Noise, Audible 82 82
Device Dislodged or Dislocated 66 66
Loosening of Implant Not Related to Bone-Ingrowth 57 57
Device Slipped 53 53
Corroded 49 49
Material Fragmentation 42 42
Material Integrity Problem 41 41
Naturally Worn 38 38
Malposition of Device 32 32
Migration 31 31
Device Appears to Trigger Rejection 27 27
Loss of Osseointegration 24 24
Mechanical Problem 24 24
Degraded 23 23
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
No Apparent Adverse Event 5 5
Protective Measures Problem 5 5
Nonstandard Device 5 5
Material Discolored 5 5
Crack 5 5
Defective Device 5 5
Material Erosion 5 5
Connection Problem 4 4
Failure To Adhere Or Bond 4 4
Detachment Of Device Component 4 4
Dull, Blunt 4 4
Use of Device Problem 3 3
Component Missing 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 1838 1839
Toxicity 1227 1229
Metal Related Pathology 956 956
No Code Available 868 869
Failure of Implant 843 843
Injury 786 786
Test Result 424 425
Osteolysis 214 214
Reaction 205 205
Loss of Range of Motion 168 168
Swelling 168 168
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 107 107
Bone Fracture(s) 99 100
Inflammation 99 99
No Clinical Signs, Symptoms or Conditions 91 91
Arthralgia 87 87
Insufficient Information 78 78
Joint Dislocation 75 75
Joint Swelling 73 73
Cyst(s) 72 72
Limited Mobility Of The Implanted Joint 68 68
Tissue Damage 67 67
Muscle Weakness 63 63
Synovitis 56 56
Hip Fracture 55 55
Debris, Bone Shedding 54 54
Inadequate Osseointegration 45 45
Foreign Body Reaction 42 42
Complaint, Ill-Defined 40 40
Implant Pain 34 34
Hypersensitivity/Allergic reaction 30 30
Fall 30 30
Joint Laxity 29 29
Unequal Limb Length 27 27
Host-Tissue Reaction 25 25
Ossification 25 25
Solid Tumour 23 23
Chemical Exposure 23 23
Swelling/ Edema 22 22
Foreign Body In Patient 21 21
Deformity/ Disfigurement 19 19
Fatigue 18 18
Bacterial Infection 18 18

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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