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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device spacer, cement
Product CodeLTO
Regulation Number 888.3320
Device Class 3

MDR Year MDR Reports MDR Events
2014 4 4
2015 4 4
2016 4 4
2017 2 2
2018 4 4
2019 6 6
2020 3 3
2021 17 17
2022 3 3
2023 1 1
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 27 27
Insufficient Information 12 12
Use of Device Problem 6 6
Loss of or Failure to Bond 4 4
Migration 3 3
Appropriate Term/Code Not Available 2 2
Fracture 1 1
Delivered as Unsterile Product 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 18 18
Pain 15 15
No Code Available 15 15
Insufficient Information 8 8
Foreign Body Reaction 5 5
Pulmonary Embolism 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Adhesion(s) 2 2
Arrhythmia 2 2
Inflammation 2 2
Loss of Range of Motion 2 2
Joint Laxity 2 2
No Information 2 2
Discomfort 2 2
Osteolysis 1 1
Post Operative Wound Infection 1 1
Diaphoresis 1 1
Myocarditis 1 1
Ambulation Difficulties 1 1
Blood Loss 1 1
Inadequate Osseointegration 1 1
Limited Mobility Of The Implanted Joint 1 1
Foreign Body In Patient 1 1
Host-Tissue Reaction 1 1
Pneumonia 1 1
Unspecified Tissue Injury 1 1
Swelling/ Edema 1 1
Thrombosis/Thrombus 1 1
Scar Tissue 1 1
Swelling 1 1
Thrombosis 1 1
Vomiting 1 1
Weakness 1 1
Burning Sensation 1 1
Chills 1 1
No Consequences Or Impact To Patient 1 1
Distress 1 1
Necrosis 1 1
Bone Fracture(s) 1 1
Hemorrhage/Bleeding 1 1
Death 1 1
Edema 1 1
Embolism 1 1
No Clinical Signs, Symptoms or Conditions 1 1

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