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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 131 131

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 989 989
Biocompatibility 717 717
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 56 56
Fracture 40 40
Loose or Intermittent Connection 38 38
Corroded 34 34
Noise, Audible 30 30
Migration 30 30
Device Appears to Trigger Rejection 27 27
Device Dislodged or Dislocated 26 26
Material Fragmentation 26 26
Loss of Osseointegration 22 22
Naturally Worn 20 20
Patient-Device Incompatibility 20 20
Degraded 18 18
Malposition of Device 14 14
Device Slipped 9 9
Unstable 8 8
Mechanical Problem 8 8
Material Disintegration 8 8
Therapeutic or Diagnostic Output Failure 8 8
Material Twisted/Bent 6 6
Defective Device 5 5
Pitted 4 4
Inadequacy of Device Shape and/or Size 4 4
No Apparent Adverse Event 4 4
Collapse 4 4
Dull, Blunt 4 4
Detachment of Device or Device Component 3 3
Material Erosion 3 3
Improper or Incorrect Procedure or Method 3 3
Osseointegration Problem 3 3
Crack 3 3
Material Discolored 2 2
Use of Device Problem 2 2
Failure to Osseointegrate 2 2
Material Separation 2 2
Unintended Movement 2 2
Connection Problem 2 2
Migration or Expulsion of Device 2 2
Contamination /Decontamination Problem 1 1
Positioning Failure 1 1
Component Missing 1 1
Failure to Align 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Metal Related Pathology 953 953
Pain 879 879
Injury 472 472
Toxicity 325 326
Failure of Implant 309 309
Test Result 176 176
Loss of Range of Motion 148 148
Osteolysis 136 136
Infiltration into Tissue 123 123
No Code Available 93 93
No Clinical Signs, Symptoms or Conditions 91 91
Unspecified Infection 89 89
Discomfort 79 79
Ambulation Difficulties 79 79
Arthralgia 78 78
Insufficient Information 76 76
Bone Fracture(s) 62 62
Inflammation 60 60
Cyst(s) 58 58
No Known Impact Or Consequence To Patient 54 54
Necrosis 51 51
Joint Dislocation 49 49
Hip Fracture 47 47
Inadequate Osseointegration 45 45
Limited Mobility Of The Implanted Joint 43 43
Synovitis 41 41
Swelling 35 35
Foreign Body Reaction 34 34
Implant Pain 34 34
Reaction 33 33
Joint Laxity 29 29
Unequal Limb Length 27 27
Debris, Bone Shedding 27 27
No Information 26 26
Solid Tumour 23 23
Swelling/ Edema 22 22
Ossification 21 21
Tissue Damage 20 20
Deformity/ Disfigurement 19 19
Unspecified Tissue Injury 16 16
Neuralgia 15 15
Fall 15 15
Bacterial Infection 14 14
Osteopenia/ Osteoporosis 13 13
Memory Loss/Impairment 12 12
Fatigue 10 10
Tissue Breakdown 9 9
Hematoma 9 9
Muscle Weakness 9 9
Muscular Rigidity 8 8

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