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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
Product CodeJDJ
Regulation Number 878.3300
Device Class 2

MDR Year MDR Reports MDR Events
2019 34 34
2020 14 14
2021 14 14
2022 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 34 34
Fracture 10 10
Osseointegration Problem 9 9
Migration 8 8
Loss of Osseointegration 7 7
Unintended Movement 1 1
Positioning Failure 1 1
Naturally Worn 1 1
Device Dislodged or Dislocated 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 30 30
Pain 24 24
Unspecified Infection 22 22
Discomfort 16 16
Inadequate Osseointegration 16 16
Insufficient Information 13 13
Thrombosis 9 9
Tissue Damage 8 8
Joint Laxity 8 8
Physical Asymmetry 8 8
Limited Mobility Of The Implanted Joint 8 8
Scar Tissue 7 7
Adhesion(s) 7 7
Injury 2 2
Joint Dislocation 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Bone Fracture(s) 1 1
Hematoma 1 1
Hemorrhage/Bleeding 1 1

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