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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 12

MDR Year MDR Reports MDR Events
2020 371 371
2021 109 109
2022 89 89
2023 133 133
2024 119 119
2025 37 256

Device Problems MDRs with this Device Problem Events in those MDRs
Break 226 226
Adverse Event Without Identified Device or Use Problem 209 428
Fracture 188 272
Device Dislodged or Dislocated 43 127
Noise, Audible 39 39
Material Twisted/Bent 32 32
Insufficient Information 24 24
Loosening of Implant Not Related to Bone-Ingrowth 22 22
Osseointegration Problem 17 221
Naturally Worn 16 16
Loss of Osseointegration 13 13
Degraded 12 12
Patient Device Interaction Problem 10 10
Device-Device Incompatibility 9 9
Biocompatibility 8 8
Crack 8 8
Difficult to Insert 8 8
Unstable 7 7
Material Deformation 7 7
Malposition of Device 6 110
Appropriate Term/Code Not Available 6 6
Migration 6 6
Use of Device Problem 6 6
Material Erosion 5 105
Failure to Osseointegrate 5 5
Device Slipped 4 4
Unsealed Device Packaging 4 4
Difficult to Remove 4 4
Detachment of Device or Device Component 4 4
Improper or Incorrect Procedure or Method 3 3
Loose or Intermittent Connection 3 3
Corroded 3 3
Unintended Movement 3 3
Positioning Failure 3 3
Connection Problem 2 2
Inadequacy of Device Shape and/or Size 2 2
Packaging Problem 2 2
Delivered as Unsterile Product 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
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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 233 233
Pain 146 246
Insufficient Information 109 328
No Code Available 108 108
No Clinical Signs, Symptoms or Conditions 97 97
Failure of Implant 66 66
Unspecified Infection 56 275
Joint Dislocation 49 268
Metal Related Pathology 46 46
Bone Fracture(s) 27 146
Ambulation Difficulties 22 22
Osteolysis 20 104
Injury 19 19
Foreign Body Reaction 19 19
Inadequate Osseointegration 16 100
Joint Laxity 15 119
Loss of Range of Motion 15 15
Not Applicable 14 14
Discomfort 13 13
Muscle/Tendon Damage 12 12
Swelling/ Edema 11 11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 10 10
Fall 9 9
Ossification 9 9
No Information 9 9
Synovitis 8 8
Hip Fracture 8 8
Unequal Limb Length 8 24
Cyst(s) 7 7
Adhesion(s) 7 7
Unspecified Tissue Injury 7 7
Foreign Body In Patient 7 7
Inflammation 6 6
Thrombosis/Thrombus 6 6
Limited Mobility Of The Implanted Joint 6 6
Edema 5 5
Physical Asymmetry 5 5
Arthralgia 5 5
Limb Fracture 5 5
Scar Tissue 5 5
Hypersensitivity/Allergic reaction 4 4
No Known Impact Or Consequence To Patient 4 4
Nerve Damage 4 4
Deformity/ Disfigurement 3 207
Test Result 3 3
Impaired Healing 2 2
Pulmonary Embolism 2 2
Hemorrhage/Bleeding 2 2
Tissue Damage 2 2
Nodule 2 2

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