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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)
Regulation Description Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis.
Product CodeJDL
Regulation Number 888.3320
Device Class 3

MDR Year MDR Reports MDR Events
2020 94 94
2021 68 73
2022 49 49
2023 32 34
2024 27 27
2025 17 17
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 75 76
Corroded 67 68
Device Dislodged or Dislocated 33 33
Material Disintegration 28 28
Break 19 19
Appropriate Term/Code Not Available 18 18
Detachment of Device or Device Component 13 13
Loss of Osseointegration 12 12
Adverse Event Without Identified Device or Use Problem 11 12
Material Erosion 10 13
Fracture 9 9
Naturally Worn 8 8
Unstable 5 5
Patient-Device Incompatibility 5 8
Noise, Audible 5 6
Material Frayed 4 4
Malposition of Device 4 4
Patient Device Interaction Problem 4 5
Mechanical Problem 3 3
Difficult to Remove 3 3
Compatibility Problem 2 2
Therapeutic or Diagnostic Output Failure 2 4
Material Fragmentation 2 2
Fitting Problem 1 1
Device-Device Incompatibility 1 1
Crack 1 1
Peeled/Delaminated 1 1
Material Integrity Problem 1 1
Positioning Problem 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Difficult to Insert 1 1
Shipping Damage or Problem 1 1
Material Discolored 1 1
Use of Device Problem 1 1
Migration 1 1
Loose or Intermittent Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 105 112
Metal Related Pathology 98 104
Insufficient Information 37 37
No Information 33 33
Reaction 22 22
Unspecified Infection 18 18
Failure of Implant 18 20
Loss of Range of Motion 13 14
Joint Dislocation 6 6
Osteolysis 6 8
Osteopenia/ Osteoporosis 5 7
Tissue Damage 4 4
Swelling/ Edema 4 4
Unequal Limb Length 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Ambulation Difficulties 3 4
No Code Available 3 3
Unspecified Tissue Injury 3 3
Injury 3 3
Headache 2 4
Toxicity 2 2
Dyspnea 2 4
Nerve Damage 2 2
Swelling 2 2
Neck Pain 2 4
Rash 2 4
Local Reaction 2 2
Bone Fracture(s) 2 2
Synovitis 2 3
Dizziness 2 4
Nausea 2 4
No Clinical Signs, Symptoms or Conditions 2 2
Neuropathy 2 2
No Known Impact Or Consequence To Patient 1 1
Cyst(s) 1 1
Prolapse 1 1
Fluid Discharge 1 1
Muscle/Tendon Damage 1 2
Host-Tissue Reaction 1 1
Necrosis 1 1
Hypersensitivity/Allergic reaction 1 1
Wound Dehiscence 1 1
Bacterial Infection 1 2

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