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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)
2020 2021 2022 2023 2024 2025
13 18 33 19 16 0

MDR Year MDR Reports MDR Events
2020 371 371
2021 109 109
2022 89 89
2023 133 133
2024 118 118

Device Problems MDRs with this Device Problem Events in those MDRs
Break 226 226
Adverse Event Without Identified Device or Use Problem 195 195
Fracture 169 169
Device Dislodged or Dislocated 41 41
Noise, Audible 37 37
Material Twisted/Bent 32 32
Insufficient Information 24 24
Loosening of Implant Not Related to Bone-Ingrowth 22 22
Naturally Worn 16 16
Loss of Osseointegration 13 13
Osseointegration Problem 13 13
Degraded 11 11
Patient Device Interaction Problem 10 10
Device-Device Incompatibility 9 9
Biocompatibility 8 8
Crack 8 8
Unstable 7 7
Difficult to Insert 7 7
Material Deformation 7 7
Appropriate Term/Code Not Available 6 6
Use of Device Problem 6 6
Malposition of Device 5 5
Migration 5 5
Device Slipped 4 4
Detachment of Device or Device Component 4 4
Difficult to Remove 4 4
Failure to Osseointegrate 4 4
Loose or Intermittent Connection 3 3
Corroded 3 3
Material Erosion 3 3
Unintended Movement 3 3
Unsealed Device Packaging 3 3
Positioning Failure 3 3
Connection Problem 2 2
Inadequacy of Device Shape and/or Size 2 2
Packaging Problem 2 2
Component Missing 2 2
Patient-Device Incompatibility 2 2
Device Damaged Prior to Use 2 2
Difficult to Open or Remove Packaging Material 2 2
Mechanical Problem 2 2
Device Contaminated During Manufacture or Shipping 2 2
Material Frayed 2 2
Delivered as Unsterile Product 1 1
Device Damaged by Another Device 1 1
Contamination /Decontamination Problem 1 1
Tear, Rip or Hole in Device Packaging 1 1
Positioning Problem 1 1
Material Integrity Problem 1 1
Separation Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 233 233
Pain 140 140
No Code Available 108 108
Insufficient Information 99 99
No Clinical Signs, Symptoms or Conditions 86 86
Failure of Implant 64 64
Unspecified Infection 49 49
Metal Related Pathology 46 46
Joint Dislocation 41 41
Bone Fracture(s) 24 24
Ambulation Difficulties 22 22
Injury 19 19
Foreign Body Reaction 19 19
Osteolysis 18 18
Inadequate Osseointegration 14 14
Not Applicable 14 14
Loss of Range of Motion 14 14
Joint Laxity 13 13
Muscle/Tendon Damage 12 12
Discomfort 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 10 10
Swelling/ Edema 10 10
No Information 9 9
Ossification 9 9
Fall 9 9
Synovitis 8 8
Hip Fracture 8 8
Adhesion(s) 7 7
Cyst(s) 7 7
Unequal Limb Length 7 7
Inflammation 6 6
Unspecified Tissue Injury 6 6
Foreign Body In Patient 6 6
Thrombosis/Thrombus 6 6
Limited Mobility Of The Implanted Joint 6 6
Edema 5 5
Limb Fracture 5 5
Scar Tissue 5 5
Arthralgia 5 5
Physical Asymmetry 4 4
No Known Impact Or Consequence To Patient 4 4
Hypersensitivity/Allergic reaction 4 4
Nerve Damage 4 4
Test Result 3 3
Impaired Healing 2 2
Pulmonary Embolism 2 2
Hemorrhage/Bleeding 2 2
Tissue Damage 2 2
Nodule 2 2
Subluxation 2 2

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