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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 0

MDR Year MDR Reports MDR Events
2017 540 540
2018 694 694
2019 641 641
2020 371 371
2021 110 110

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1234 1234
Insufficient Information 233 233
Fracture 203 203
Adverse Event Without Identified Device or Use Problem 160 160
Device Dislodged or Dislocated 91 91
Appropriate Term/Code Not Available 66 66
Noise, Audible 66 66
Material Twisted/Bent 57 57
Naturally Worn 52 52
Crack 49 49
Material Deformation 42 42
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 18 18
Difficult to Remove 15 15
Unstable 15 15
Migration or Expulsion of Device 13 13
Connection Problem 12 12
Degraded 12 12
Disassembly 12 12
Corroded 11 11
Loss of or Failure to Bond 11 11
Loosening of Implant Not Related to Bone-Ingrowth 11 11
Use of Device Problem 9 9
Metal Shedding Debris 9 9
Unintended Movement 8 8
Detachment of Device or Device Component 7 7
Inadequacy of Device Shape and/or Size 7 7
Difficult to Insert 6 6
Material Fragmentation 6 6
Fitting Problem 6 6
Physical Resistance/Sticking 6 6
Positioning Failure 5 5
Device Slipped 5 5
Mechanical Problem 4 4
Material Erosion 4 4
Component Missing 4 4
Mechanical Jam 4 4
Migration 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
Failure to Osseointegrate 3 3
Unsealed Device Packaging 2 2
Bent 2 2
Defective Device 2 2
Patient-Device Incompatibility 2 2
Biocompatibility 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
Contamination /Decontamination Problem 1 1
Ambient Noise 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
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
No Information 290 290
Pain 279 279
No Code Available 248 248
Injury 148 148
Not Applicable 136 136
Unspecified Infection 113 113
No Known Impact Or Consequence To Patient 82 82
Joint Dislocation 61 61
Inadequate Osseointegration 45 45
Bone Fracture(s) 39 39
Failure of Implant 35 35
Discomfort 33 33
Tissue Damage 30 30
Inflammation 28 28
No Clinical Signs, Symptoms or Conditions 28 28
Foreign Body Reaction 25 25
Ambulation Difficulties 22 22
Insufficient Information 22 22
Limited Mobility Of The Implanted Joint 20 20
Test Result 20 20
Loss of Range of Motion 19 19
Osteolysis 15 15
Reaction 14 14
Swelling 14 14
Joint Disorder 13 13
Metal Related Pathology 13 13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 10 10
Necrosis 10 10
Hematoma 10 10
Hypersensitivity/Allergic reaction 9 9
Host-Tissue Reaction 9 9
Ossification 9 9
Fall 9 9
Foreign Body In Patient 9 9
Blood Loss 9 9
Weakness 8 8
Edema 8 8
Scar Tissue 7 7
No Patient Involvement 6 6
Death 6 6
Myocardial Infarction 5 5
Physical Asymmetry 5 5
Swelling/ Edema 4 4
Adhesion(s) 4 4
Device Embedded In Tissue or Plaque 4 4
Post Operative Wound Infection 4 4
Hip Fracture 4 4
Synovitis 4 4
Thrombosis 3 3
Skin Irritation 3 3
Infarction, Cerebral 3 3
Muscular Rigidity 3 3
High Blood Pressure/ Hypertension 3 3
Unequal Limb Length 3 3
Joint Laxity 3 3
Nodule 2 2
Muscle/Tendon Damage 2 2
Thrombosis/Thrombus 2 2
Subluxation 2 2
Nausea 2 2
Rash 2 2
Staphylococcus Aureus 2 2
Bacterial Infection 2 2
Fatigue 2 2
Fever 2 2
Abscess 2 2
Calcium Deposits/Calcification 2 2
Cardiac Arrest 2 2
Chills 2 2
Toxicity 2 2
Arthralgia 2 2
Impaired Healing 2 2
Depression 1 1
Hypoesthesia 1 1
Fibrosis 1 1
Anxiety 1 1
Distress 1 1
Dizziness 1 1
Vomiting 1 1
Sepsis 1 1
Nerve Damage 1 1
Cellulitis 1 1
Stroke/CVA 1 1
Anemia 1 1
Arthritis 1 1
Ecchymosis 1 1
Erosion 1 1
Chest Pain 1 1
Hemorrhage/Bleeding 1 1
Headache 1 1
Unspecified Tissue Injury 1 1
Implant Pain 1 1

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