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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 cemented acetabular component)
Product CodeJDL
Regulation Number 888.3320
Device Class 3

MDR Year MDR Reports MDR Events
2019 140 140
2020 94 94
2021 68 68
2022 49 49
2023 33 33
2024 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 148 148
Corroded 70 70
Device Dislodged or Dislocated 47 47
Material Disintegration 46 46
Break 20 20
Appropriate Term/Code Not Available 18 18
Detachment of Device or Device Component 15 15
Material Erosion 14 14
Adverse Event Without Identified Device or Use Problem 13 13
Loss of Osseointegration 12 12
Naturally Worn 12 12
Fracture 9 9
Unstable 6 6
Patient-Device Incompatibility 6 6
Noise, Audible 6 6
Material Frayed 5 5
Malposition of Device 4 4
Patient Device Interaction Problem 3 3
Loose or Intermittent Connection 3 3
Difficult to Remove 3 3
Migration 3 3
Therapeutic or Diagnostic Output Failure 2 2
Mechanical Problem 2 2
Material Fragmentation 2 2
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Compatibility Problem 2 2
Material Integrity Problem 1 1
Material Twisted/Bent 1 1
Positioning Problem 1 1
Device-Device Incompatibility 1 1
Crack 1 1
Degraded 1 1
Material Discolored 1 1
Difficult to Insert 1 1
Shipping Damage or Problem 1 1
Use of Device Problem 1 1
Fitting Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 118 118
Reaction 98 98
Metal Related Pathology 90 90
No Information 57 57
Insufficient Information 32 32
Unspecified Infection 32 32
Failure of Implant 23 23
Loss of Range of Motion 14 14
Joint Dislocation 11 11
Tissue Damage 8 8
Osteolysis 7 7
Injury 6 6
Bone Fracture(s) 5 5
Necrosis 4 4
Swelling 4 4
Synovitis 4 4
Osteopenia/ Osteoporosis 4 4
Unequal Limb Length 4 4
Unspecified Tissue Injury 3 3
Swelling/ Edema 3 3
No Code Available 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Toxicity 3 3
Local Reaction 3 3
Dizziness 2 2
Discomfort 2 2
Limited Mobility Of The Implanted Joint 2 2
Fluid Discharge 2 2
No Known Impact Or Consequence To Patient 2 2
Neck Pain 2 2
Nerve Damage 2 2
Neuropathy 2 2
Rash 2 2
Dyspnea 2 2
Nausea 2 2
Headache 2 2
Wound Dehiscence 2 2
Ossification 2 2
Adhesion(s) 1 1
Bacterial Infection 1 1
Cyst(s) 1 1
Host-Tissue Reaction 1 1
Hypersensitivity/Allergic reaction 1 1
Neck Stiffness 1 1
Prolapse 1 1
Ambulation Difficulties 1 1
Hip Fracture 1 1
Scar Tissue 1 1
Tentorial Tears 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Impaired Healing 1 1
Muscle/Tendon Damage 1 1

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