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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/ceramic/ceramic/metal, cemented or uncemented
Product CodeMRA
Device Class 3

Premarket Approvals (PMA)
2017 2018 2019 2020 2021 2022
16 11 17 13 18 32

MDR Year MDR Reports MDR Events
2017 540 540
2018 695 695
2019 641 641
2020 372 372
2021 112 112
2022 71 71

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1236 1236
Insufficient Information 235 235
Fracture 224 224
Adverse Event Without Identified Device or Use Problem 190 190
Device Dislodged or Dislocated 100 100
Appropriate Term/Code Not Available 67 67
Noise, Audible 67 67
Material Twisted/Bent 57 57
Naturally Worn 53 53
Crack 49 49
Material Deformation 43 43
Loss of Osseointegration 37 37
Loose or Intermittent Connection 31 31
Malposition of Device 26 26
Scratched Material 25 25
Device-Device Incompatibility 22 22
Osseointegration Problem 19 19
Unstable 16 16
Difficult to Remove 15 15
Loosening of Implant Not Related to Bone-Ingrowth 15 15
Degraded 13 13
Migration or Expulsion of Device 13 13
Connection Problem 12 12
Disassembly 12 12
Corroded 12 12
Loss of or Failure to Bond 11 11
Use of Device Problem 10 10
Metal Shedding Debris 9 9
Detachment of Device or Device Component 8 8
Unintended Movement 8 8
Inadequacy of Device Shape and/or Size 7 7
Difficult to Insert 7 7
Material Fragmentation 6 6
Fitting Problem 6 6
Physical Resistance/Sticking 6 6
Migration 5 5
Biocompatibility 5 5
Mechanical Jam 5 5
Positioning Failure 5 5
Device Slipped 5 5
Failure to Osseointegrate 4 4
Mechanical Problem 4 4
Material Erosion 4 4
Component Missing 4 4
Failure to Disconnect 3 3
Dull, Blunt 3 3
Material Disintegration 3 3
Failure To Adhere Or Bond 3 3
Device Inoperable 3 3
Unsealed Device Packaging 2 2
Bent 2 2
Defective Device 2 2
Patient-Device Incompatibility 2 2
Device Damaged by Another Device 2 2
Material Integrity Problem 2 2
Positioning Problem 2 2
Device Disinfection Or Sterilization Issue 1 1
Difficult to Open or Remove Packaging Material 1 1
Material Distortion 1 1
Device Contaminated During Manufacture or Shipping 1 1
Ambient Noise Problem 1 1
Contamination /Decontamination Problem 1 1
Separation Failure 1 1
Out-Of-Box Failure 1 1
Device Issue 1 1
Failure to Advance 1 1
Device Damaged Prior to Use 1 1
Misconnection 1 1
Material Discolored 1 1
Entrapment of Device 1 1
Flaked 1 1
Material Frayed 1 1
Peeled/Delaminated 1 1
Difficult To Position 1 1
Device Difficult to Setup or Prepare 1 1
Off-Label Use 1 1
Device Appears to Trigger Rejection 1 1
Device Abrasion From Instrument Or Another Object 1 1
Incorrect Measurement 1 1
Material Split, Cut or Torn 1 1
Activation Problem 1 1
Separation Problem 1 1
Patient Device Interaction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 1129 1129
Pain 300 300
No Information 290 290
No Code Available 249 249
Injury 149 149
Not Applicable 136 136
Unspecified Infection 120 120
No Known Impact Or Consequence To Patient 82 82
Joint Dislocation 74 74
Inadequate Osseointegration 47 47
Bone Fracture(s) 42 42
Failure of Implant 41 41
No Clinical Signs, Symptoms or Conditions 41 41
Insufficient Information 37 37
Discomfort 35 35
Tissue Damage 30 30
Inflammation 28 28
Foreign Body Reaction 26 26
Ambulation Difficulties 26 26
Loss of Range of Motion 22 22
Metal Related Pathology 22 22
Test Result 20 20
Limited Mobility Of The Implanted Joint 20 20
Osteolysis 17 17
Reaction 14 14
Swelling 14 14
Joint Disorder 13 13
Fall 12 12
Hematoma 11 11
Hypersensitivity/Allergic reaction 10 10
Ossification 10 10
Necrosis 10 10
Foreign Body In Patient 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 10 10
Blood Loss 9 9
Host-Tissue Reaction 9 9
Edema 8 8
Scar Tissue 8 8
Weakness 8 8
Swelling/ Edema 7 7
No Patient Involvement 6 6
Death 6 6
Myocardial Infarction 5 5
Post Operative Wound Infection 5 5
Hip Fracture 5 5
Synovitis 5 5
Physical Asymmetry 5 5
Thrombosis/Thrombus 5 5
Joint Laxity 5 5
Unequal Limb Length 4 4
Device Embedded In Tissue or Plaque 4 4
Adhesion(s) 4 4
Infarction, Cerebral 3 3
Muscular Rigidity 3 3
High Blood Pressure/ Hypertension 3 3
Thrombosis 3 3
Skin Irritation 3 3
Muscle/Tendon Damage 3 3
Subluxation 2 2
Nodule 2 2
Distress 2 2
Toxicity 2 2
Arthralgia 2 2
Impaired Healing 2 2
Chills 2 2
Nerve Damage 2 2
Rash 2 2
Staphylococcus Aureus 2 2
Fatigue 2 2
Fever 2 2
Nausea 2 2
Bacterial Infection 2 2
Abscess 2 2
Calcium Deposits/Calcification 2 2
Cardiac Arrest 2 2
Cellulitis 1 1
Stroke/CVA 1 1
Anemia 1 1
Arthritis 1 1
Erosion 1 1
Chest Pain 1 1
Ecchymosis 1 1
Infiltration into Tissue 1 1
Headache 1 1
Hemorrhage/Bleeding 1 1
Hyperplasia 1 1
Sepsis 1 1
Dizziness 1 1
Anxiety 1 1
Vomiting 1 1
Deformity/ Disfigurement 1 1
Depression 1 1
Hypoesthesia 1 1
Unspecified Tissue Injury 1 1
Implant Pain 1 1
Malunion of Bone 1 1
Unspecified Musculoskeletal problem 1 1
Fibrosis 1 1
Cancer 1 1

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