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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)
2019 2020 2021 2022 2023 2024
17 13 18 33 19 8

MDR Year MDR Reports MDR Events
2019 641 641
2020 371 371
2021 109 109
2022 89 89
2023 134 134
2024 60 60

Device Problems MDRs with this Device Problem Events in those MDRs
Break 637 637
Adverse Event Without Identified Device or Use Problem 217 217
Fracture 191 191
Device Dislodged or Dislocated 58 58
Material Twisted/Bent 56 56
Insufficient Information 56 56
Noise, Audible 46 46
Naturally Worn 38 38
Material Deformation 32 32
Loosening of Implant Not Related to Bone-Ingrowth 26 26
Scratched Material 22 22
Crack 20 20
Device-Device Incompatibility 19 19
Loss of Osseointegration 17 17
Degraded 16 16
Osseointegration Problem 14 14
Difficult to Insert 11 11
Malposition of Device 11 11
Patient Device Interaction Problem 10 10
Appropriate Term/Code Not Available 9 9
Biocompatibility 9 9
Use of Device Problem 9 9
Migration 8 8
Detachment of Device or Device Component 7 7
Unstable 7 7
Loose or Intermittent Connection 7 7
Physical Resistance/Sticking 6 6
Unintended Movement 5 5
Difficult to Remove 5 5
Positioning Failure 5 5
Corroded 5 5
Failure to Osseointegrate 5 5
Connection Problem 5 5
Device Slipped 4 4
Unsealed Device Packaging 4 4
Inadequacy of Device Shape and/or Size 3 3
Mechanical Problem 3 3
Material Fragmentation 3 3
Component Missing 3 3
Mechanical Jam 3 3
Packaging Problem 2 2
Device Contaminated During Manufacture or Shipping 2 2
Patient-Device Incompatibility 2 2
Fitting Problem 2 2
Material Frayed 2 2
Loss of or Failure to Bond 2 2
Material Erosion 2 2
Material Disintegration 2 2
Entrapment of Device 1 1
Off-Label Use 1 1
Device Appears to Trigger Rejection 1 1
Device Damaged Prior to Use 1 1
Ambient Noise Problem 1 1
Contamination /Decontamination Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Failure to Advance 1 1
Separation Failure 1 1
Defective Device 1 1
Material Integrity Problem 1 1
Device Damaged by Another Device 1 1
Difficult to Open or Remove Packaging Material 1 1
Positioning Problem 1 1
Activation Problem 1 1
Material Split, Cut or Torn 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 643 643
Pain 187 187
No Code Available 172 172
Insufficient Information 88 88
No Clinical Signs, Symptoms or Conditions 74 74
Not Applicable 73 73
Unspecified Infection 69 69
Failure of Implant 62 62
Injury 52 52
Joint Dislocation 49 49
Metal Related Pathology 46 46
Bone Fracture(s) 28 28
Ambulation Difficulties 26 26
Foreign Body Reaction 25 25
Inadequate Osseointegration 22 22
Osteolysis 21 21
Loss of Range of Motion 19 19
No Information 19 19
Discomfort 17 17
Inflammation 14 14
Ossification 13 13
No Known Impact Or Consequence To Patient 13 13
Tissue Damage 12 12
Joint Laxity 12 12
Muscle/Tendon Damage 11 11
Foreign Body In Patient 11 11
Test Result 10 10
Scar Tissue 10 10
Limited Mobility Of The Implanted Joint 10 10
Swelling/ Edema 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 9
Adhesion(s) 9 9
Hypersensitivity/Allergic reaction 9 9
Hematoma 8 8
Fall 8 8
Synovitis 8 8
Blood Loss 7 7
Reaction 7 7
Cyst(s) 7 7
Edema 6 6
Hip Fracture 6 6
Unspecified Tissue Injury 6 6
Unequal Limb Length 5 5
Thrombosis/Thrombus 5 5
Limb Fracture 5 5
Swelling 5 5
Myocardial Infarction 5 5
Nerve Damage 4 4
Arthralgia 4 4
Joint Disorder 4 4
Post Operative Wound Infection 4 4
Physical Asymmetry 4 4
Muscular Rigidity 3 3
Necrosis 3 3
Hemorrhage/Bleeding 3 3
Fever 3 3
Abscess 3 3
Bacterial Infection 3 3
Host-Tissue Reaction 2 2
High Blood Pressure/ Hypertension 2 2
Nausea 2 2
Impaired Healing 2 2
Device Embedded In Tissue or Plaque 2 2
Skin Irritation 2 2
Chills 2 2
Weakness 2 2
Implant Pain 2 2
Unspecified Musculoskeletal problem 2 2
Nodule 2 2
Subluxation 2 2
Malunion of Bone 1 1
Cancer 1 1
Burning Sensation 1 1
Toxicity 1 1
Distress 1 1
Sepsis 1 1
Thrombosis 1 1
Vomiting 1 1
Nervous System Injury 1 1
No Patient Involvement 1 1
Osteopenia/ Osteoporosis 1 1
Rash 1 1
Infiltration into Tissue 1 1
Hyperplasia 1 1
Headache 1 1
Ecchymosis 1 1
Fatigue 1 1
Erosion 1 1
Calcium Deposits/Calcification 1 1
Cellulitis 1 1
Chest Pain 1 1
Arthritis 1 1

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