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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
2021 68 73
2022 49 49
2023 32 34
2024 27 27
2025 16 16
2026 16 16

Device Problems MDRs with this Device Problem Events in those MDRs
Corroded 50 51
Insufficient Device Problem Information 44 45
Device Dislodged or Dislocated 26 26
Break 16 16
Detachment of Device or Device Component 8 8
Loss of Osseointegration 8 8
Material Erosion 7 10
Material Disintegration 6 6
Naturally Worn 6 6
Noise, Audible 6 7
Therapeutic or Diagnostic Output Failure 5 7
Adverse Event Without Identified Device or Use Problem 5 6
Material Frayed 4 4
Fracture 4 4
Leak/Splash 3 3
Unstable 3 3
Entrapment of Device 3 3
Mechanical Problem 3 3
Difficult to Remove 3 3
Patient Device Interaction Problem 3 4
Material Fragmentation 3 3
Patient-Device Incompatibility 2 4
Malposition of Device 1 1
Crack 1 1
Peeled/Delaminated 1 1
Material Integrity Problem 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Use of Device Problem 1 1
Packaging Problem 1 1
Device Damaged Prior to Receipt by User 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Metal Related Pathology 91 97
Pain 83 90
Insufficient Information 37 37
Failure of Implant 20 22
Unspecified Infection 19 19
Loss of Range of Motion 10 11
High metal ion levels 6 6
Joint Dislocation 5 5
Osteopenia/ Osteoporosis 5 7
Osteolysis 5 7
Dyspnea 5 7
Headache 5 7
Unequal Limb Length 4 4
Swelling/ Edema 4 4
Infiltration into Tissue 4 4
Fatigue 3 3
No Clinical Signs, Symptoms or Conditions 3 3
Cognitive Changes 3 3
Foreign Body Reaction 3 3
Foreign Body In Patient 3 3
Ambulation or Postural Difficulties 3 4
Limb Pain 3 3
Unspecified Tissue Injury 3 3
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 3 3
Neuropathy 2 2
Aseptic loosening 2 2
Nausea 2 4
Dizziness 2 4
Bone Fracture(s) 2 2
Rash 2 4
Neck Pain 2 4
Radiolucent Lines 2 2
Nerve Damage 2 2
Arthrofibrosis 2 2
Hypersensitivity/Allergic reaction 1 1
Cyst(s) 1 1
Synovitis 1 2
Prolapse 1 1
Muscle/Tendon Damage 1 2
Bacterial Infection 1 2

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