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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
2014 15 15
2015 12 12
2016 5 5
2017 2 2
2018 15 15
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 40 40
Insufficient Information 21 21
Loss of Osseointegration 18 18
Fracture 14 14
Appropriate Term/Code Not Available 11 11
Osseointegration Problem 9 9
Migration 8 8
Device Dislodged or Dislocated 5 5
Naturally Worn 2 2
Break 1 1
Loose or Intermittent Connection 1 1
Unintended Movement 1 1
Positioning Failure 1 1
Failure To Adhere Or Bond 1 1
Migration or Expulsion of Device 1 1
Difficult to Remove 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 42 42
Unspecified Infection 39 39
Pain 38 38
Discomfort 17 17
Inadequate Osseointegration 16 16
Insufficient Information 13 13
Host-Tissue Reaction 12 12
Thrombosis 9 9
Pulmonary Embolism 8 8
Tissue Damage 8 8
Physical Asymmetry 8 8
Limited Mobility Of The Implanted Joint 8 8
Joint Laxity 8 8
Scar Tissue 7 7
Adhesion(s) 7 7
Injury 3 3
No Information 2 2
Failure of Implant 2 2
Bone Fracture(s) 2 2
Foreign Body Reaction 2 2
Foreign Body In Patient 1 1
Inflammation 1 1
Joint Dislocation 1 1
No Known Impact Or Consequence To Patient 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Hemorrhage/Bleeding 1 1
Hematoma 1 1

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