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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

Device Problems MDRs with this Device Problem Events in those MDRs
Corroded 67 67
Insufficient Information 64 64
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
Naturally Worn 8 8
Material Erosion 8 8
Patient-Device Incompatibility 5 5
Noise, Audible 5 5
Material Frayed 5 5
Unstable 4 4
Malposition of Device 4 4
Patient Device Interaction Problem 3 3
Difficult to Remove 3 3
Mechanical Problem 2 2
Compatibility Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Material Fragmentation 2 2
Loose or Intermittent Connection 1 1
Migration 1 1
Crack 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Difficult to Insert 1 1
Material Integrity Problem 1 1
Shipping Damage or Problem 1 1
Fitting Problem 1 1
Positioning Problem 1 1
Material Discolored 1 1
Use of Device Problem 1 1
Device-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 99 99
Metal Related Pathology 88 88
Insufficient Information 34 34
No Information 33 33
Reaction 22 22
Unspecified Infection 16 16
Failure of Implant 16 16
Loss of Range of Motion 13 13
Osteopenia/ Osteoporosis 5 5
Joint Dislocation 5 5
Osteolysis 4 4
Tissue Damage 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
Swelling/ Edema 3 3
Unspecified Tissue Injury 3 3
Headache 2 2
Bone Fracture(s) 2 2
Dyspnea 2 2
Dizziness 2 2
Synovitis 2 2
Toxicity 2 2
Swelling 2 2
Local Reaction 2 2
Rash 2 2
Neuropathy 2 2
Neck Pain 2 2
Nerve Damage 2 2
Nausea 2 2
Hypersensitivity/Allergic reaction 1 1
Cyst(s) 1 1
Muscle/Tendon Damage 1 1
Bacterial Infection 1 1
Host-Tissue Reaction 1 1
Wound Dehiscence 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Prolapse 1 1
Ambulation Difficulties 1 1
Fluid Discharge 1 1
No Known Impact Or Consequence To Patient 1 1
Necrosis 1 1

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