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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device mesh, surgical, acetabular, hip, prosthesis
Regulation Description Surgical mesh.
Product CodeJDJ
Regulation Number 878.3300
Device Class 2

MDR Year MDR Reports MDR Events
2020 14 14
2021 14 14
2022 8 8
2024 1 1
2025 2 80

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 12 90
Fracture 10 88
Migration 8 8
Loss of Osseointegration 7 7
Osseointegration Problem 4 82
Device Dislodged or Dislocated 3 81
Material Erosion 2 80
Unintended Movement 1 1
Positioning Failure 1 1
Naturally Worn 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 19 97
Insufficient Information 15 93
No Code Available 14 14
Unspecified Infection 9 87
Inadequate Osseointegration 8 8
Discomfort 8 8
Joint Laxity 8 8
Physical Asymmetry 8 8
Adhesion(s) 7 7
Scar Tissue 7 7
Joint Dislocation 3 81
Local Reaction 2 80
Osteolysis 2 80
No Clinical Signs, Symptoms or Conditions 1 1
Hematoma 1 1
Hemorrhage/Bleeding 1 1
Deformity/ Disfigurement 1 80

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