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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 68
2022 49 49
2023 33 33
2024 27 27
2025 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 69 69
Corroded 67 67
Device Dislodged or Dislocated 32 32
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 11
Fracture 9 9
Material Erosion 8 8
Naturally Worn 8 8
Material Frayed 5 5
Noise, Audible 5 5
Patient-Device Incompatibility 5 5
Malposition of Device 4 4
Unstable 4 4
Patient Device Interaction Problem 3 3
Difficult to Remove 3 3
Material Fragmentation 2 2
Therapeutic or Diagnostic Output Failure 2 2
Compatibility Problem 2 2
Mechanical Problem 2 2
Crack 1 1
Material Discolored 1 1
Material Integrity Problem 1 1
Positioning Problem 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Migration 1 1
Device-Device Incompatibility 1 1
Shipping Damage or Problem 1 1
Use of Device Problem 1 1
Fitting Problem 1 1
Difficult to Insert 1 1
Loose or Intermittent Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 102 102
Metal Related Pathology 91 91
Insufficient Information 34 34
No Information 33 33
Reaction 22 22
Failure of Implant 16 16
Unspecified Infection 16 16
Loss of Range of Motion 13 13
Osteopenia/ Osteoporosis 5 5
Joint Dislocation 5 5
Tissue Damage 4 4
Osteolysis 4 4
Swelling/ Edema 4 4
Unequal Limb Length 4 4
No Code Available 3 3
Injury 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Unspecified Tissue Injury 3 3
Dizziness 2 2
Synovitis 2 2
Swelling 2 2
Local Reaction 2 2
Rash 2 2
Neuropathy 2 2
Nerve Damage 2 2
Nausea 2 2
Headache 2 2
Bone Fracture(s) 2 2
Dyspnea 2 2
Neck Pain 2 2
Toxicity 2 2
Muscle/Tendon Damage 1 1
Hypersensitivity/Allergic reaction 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Necrosis 1 1
Cyst(s) 1 1
Bacterial Infection 1 1
Host-Tissue Reaction 1 1
Wound Dehiscence 1 1
Ambulation Difficulties 1 1
Prolapse 1 1
No Known Impact Or Consequence To Patient 1 1
Fluid Discharge 1 1

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