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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)
2018 2019 2020 2021 2022 2023
11 17 13 18 33 13

MDR Year MDR Reports MDR Events
2018 696 696
2019 641 641
2020 371 371
2021 110 110
2022 89 89
2023 93 93

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1017 1017
Adverse Event Without Identified Device or Use Problem 213 213
Fracture 202 202
Insufficient Information 129 129
Device Dislodged or Dislocated 69 69
Material Twisted/Bent 57 57
Noise, Audible 55 55
Naturally Worn 50 50
Appropriate Term/Code Not Available 41 41
Material Deformation 39 39
Crack 37 37
Osseointegration Problem 29 29
Loosening of Implant Not Related to Bone-Ingrowth 25 25
Scratched Material 23 23
Device-Device Incompatibility 23 23
Loss of Osseointegration 23 23
Loose or Intermittent Connection 18 18
Malposition of Device 15 15
Degraded 14 14
Unstable 14 14
Difficult to Remove 12 12
Use of Device Problem 10 10
Patient Device Interaction Problem 10 10
Connection Problem 9 9
Detachment of Device or Device Component 7 7
Unintended Movement 7 7
Difficult to Insert 7 7
Migration or Expulsion of Device 6 6
Corroded 6 6
Migration 6 6
Physical Resistance/Sticking 6 6
Mechanical Jam 5 5
Biocompatibility 5 5
Loss of or Failure to Bond 5 5
Positioning Failure 5 5
Material Fragmentation 5 5
Inadequacy of Device Shape and/or Size 5 5
Failure to Osseointegrate 5 5
Fitting Problem 5 5
Device Slipped 4 4
Unsealed Device Packaging 4 4
Mechanical Problem 4 4
Material Erosion 4 4
Material Disintegration 3 3
Failure To Adhere Or Bond 3 3
Metal Shedding Debris 3 3
Component Missing 3 3
Patient-Device Incompatibility 3 3
Failure to Disconnect 3 3
Positioning Problem 3 3
Packaging Problem 2 2
Defective Device 2 2
Device Damaged by Another Device 2 2
Device Contaminated During Manufacture or Shipping 2 2
Dull, Blunt 2 2
Device Damaged Prior to Use 2 2
Disassembly 2 2
Material Frayed 2 2
Device Abrasion From Instrument Or Another Object 1 1
Entrapment of Device 1 1
Flaked 1 1
Material Discolored 1 1
Improper or Incorrect Procedure or Method 1 1
Device Issue 1 1
Peeled/Delaminated 1 1
Device Difficult to Setup or Prepare 1 1
Off-Label Use 1 1
Device Appears to Trigger Rejection 1 1
Difficult to Open or Remove Packaging Material 1 1
Device Disinfection Or Sterilization Issue 1 1
Separation Failure 1 1
Failure to Advance 1 1
Ambient Noise Problem 1 1
Contamination /Decontamination Problem 1 1
Material Integrity Problem 1 1
Material Split, Cut or Torn 1 1
Activation Problem 1 1
Separation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 1064 1064
Pain 254 254
No Code Available 202 202
Not Applicable 134 134
Injury 116 116
Unspecified Infection 93 93
Failure of Implant 58 58
Joint Dislocation 57 57
Insufficient Information 57 57
No Clinical Signs, Symptoms or Conditions 57 57
No Information 52 52
Inadequate Osseointegration 46 46
Metal Related Pathology 41 41
Ambulation Difficulties 31 31
Discomfort 29 29
Foreign Body Reaction 27 27
Bone Fracture(s) 26 26
Tissue Damage 26 26
Inflammation 25 25
Loss of Range of Motion 23 23
No Known Impact Or Consequence To Patient 21 21
Osteolysis 21 21
Test Result 19 19
Limited Mobility Of The Implanted Joint 16 16
Ossification 12 12
Hematoma 11 11
Swelling 11 11
Scar Tissue 11 11
Foreign Body In Patient 11 11
Muscle/Tendon Damage 11 11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 11 11
Swelling/ Edema 10 10
Joint Laxity 10 10
Fall 10 10
Hypersensitivity/Allergic reaction 9 9
Blood Loss 9 9
Reaction 9 9
Adhesion(s) 8 8
Edema 7 7
Cyst(s) 7 7
Joint Disorder 7 7
Weakness 6 6
Synovitis 5 5
No Patient Involvement 5 5
Hip Fracture 5 5
Host-Tissue Reaction 5 5
Necrosis 5 5
Unspecified Tissue Injury 5 5
Thrombosis/Thrombus 5 5
Physical Asymmetry 5 5
Unequal Limb Length 4 4
Nerve Damage 4 4
Muscular Rigidity 4 4
Myocardial Infarction 4 4
Arthralgia 4 4
Post Operative Wound Infection 4 4
Device Embedded In Tissue or Plaque 4 4
Thrombosis 3 3
Fatigue 3 3
Fever 3 3
Infarction, Cerebral 3 3
Abscess 3 3
Bacterial Infection 3 3
Cardiac Arrest 2 2
Death 2 2
Nausea 2 2
Rash 2 2
High Blood Pressure/ Hypertension 2 2
Hemorrhage/Bleeding 2 2
Skin Irritation 2 2
Toxicity 2 2
Chills 2 2
Distress 2 2
Impaired Healing 2 2
Unspecified Musculoskeletal problem 2 2
Nodule 2 2
Implant Pain 2 2
Subluxation 2 2
Malunion of Bone 1 1
Limb Fracture 1 1
Cancer 1 1
Numbness 1 1
Depression 1 1
Hypoesthesia 1 1
Fibrosis 1 1
Burning Sensation 1 1
Anxiety 1 1
Sepsis 1 1
Vomiting 1 1
Hyperplasia 1 1
Headache 1 1
Infiltration into Tissue 1 1
Ecchymosis 1 1
Chest Pain 1 1
Cellulitis 1 1
Erosion 1 1
Calcium Deposits/Calcification 1 1
Anemia 1 1
Arthritis 1 1

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