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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
Definition This type of device is designed to allow for motion between the plastic tibial bearing and metal tibial baseplate components of a unicompartmental knee prosthesis. It is intended to replace part of a knee joint in order to relieve pain and restore knee function, for indications such as osteoarthritis and avascular necrosis.
Product CodeNRA
Device Class 3

Premarket Approvals (PMA)
2018 2019 2020 2021 2022 2023
14 12 2 1 3 1

MDR Year MDR Reports MDR Events
2018 251 251
2019 518 518
2020 190 190
2021 234 234
2022 284 284
2023 83 83

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 454 454
Adverse Event Without Identified Device or Use Problem 429 429
Patient Device Interaction Problem 133 133
Appropriate Term/Code Not Available 125 125
Device Dislodged or Dislocated 114 114
Fracture 90 90
Loose or Intermittent Connection 67 67
Loosening of Implant Not Related to Bone-Ingrowth 64 64
Break 54 54
Material Integrity Problem 50 50
Mechanical Problem 38 38
Unintended Movement 31 31
Unstable 25 25
Migration 21 21
Manufacturing, Packaging or Shipping Problem 12 12
Use of Device Problem 11 11
Noise, Audible 11 11
Packaging Problem 8 8
Migration or Expulsion of Device 8 8
Degraded 8 8
Collapse 6 6
Tear, Rip or Hole in Device Packaging 6 6
Naturally Worn 5 5
Unsealed Device Packaging 4 4
Delivered as Unsterile Product 3 3
No Device Output 3 3
Fitting Problem 3 3
Difficult to Open or Remove Packaging Material 3 3
Malposition of Device 3 3
Detachment of Device or Device Component 3 3
Device Markings/Labelling Problem 3 3
Missing Information 3 3
Material Twisted/Bent 3 3
Mechanical Jam 2 2
Patient-Device Incompatibility 2 2
Device-Device Incompatibility 2 2
Inaccurate Delivery 2 2
Improper or Incorrect Procedure or Method 2 2
Problem with Sterilization 2 2
Off-Label Use 2 2
Device Appears to Trigger Rejection 2 2
Shipping Damage or Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Product Quality Problem 1 1
Pitted 1 1
Labelling, Instructions for Use or Training Problem 1 1
Component Incompatible 1 1
Material Erosion 1 1
Loss of or Failure to Bond 1 1
Dull, Blunt 1 1
Structural Problem 1 1
Device Packaging Compromised 1 1
Output Problem 1 1
Positioning Problem 1 1
Scratched Material 1 1
Misassembly by Users 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 455 455
No Information 387 387
Insufficient Information 176 176
Failure of Implant 108 108
No Code Available 107 107
Joint Dislocation 104 104
No Clinical Signs, Symptoms or Conditions 53 53
Ambulation Difficulties 52 52
No Known Impact Or Consequence To Patient 46 46
Unspecified Infection 41 41
Swelling 39 39
Swelling/ Edema 38 38
No Consequences Or Impact To Patient 36 36
Loss of Range of Motion 31 31
Bone Fracture(s) 30 30
Arthritis 30 30
Edema 18 18
Damage to Ligament(s) 15 15
Sleep Dysfunction 13 13
No Patient Involvement 13 13
Death 12 12
Wound Dehiscence 11 11
Hematoma 10 10
Hypersensitivity/Allergic reaction 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 10 10
Inflammation 8 8
Discomfort 8 8
Synovitis 7 7
Metal Related Pathology 7 7
Joint Swelling 6 6
Collapse 6 6
Hemorrhage/Bleeding 6 6
Cyst(s) 6 6
Pulmonary Embolism 5 5
Fall 5 5
Osteolysis 5 5
Osteopenia/ Osteoporosis 4 4
Skin Inflammation/ Irritation 4 4
Implant Pain 4 4
Cramp(s) /Muscle Spasm(s) 4 4
Fatigue 4 4
Fever 4 4
Loss of Vision 4 4
Local Reaction 4 4
Scar Tissue 4 4
Seroma 3 3
Skin Irritation 3 3
Necrosis 3 3
Rash 3 3
Injury 3 3
Overwear Syndrome 3 3
Aspiration/Inhalation 3 3
High Blood Pressure/ Hypertension 3 3
Hyperextension 3 3
Joint Laxity 3 3
Tissue Breakdown 3 3
Foreign Body In Patient 3 3
Impaired Healing 3 3
Reaction 3 3
Fungal Infection 3 3
Post Operative Wound Infection 2 2
Adhesion(s) 2 2
Erosion 1 1
Abdominal Pain 1 1
Muscle Weakness 1 1
Joint Disorder 1 1
Limited Mobility Of The Implanted Joint 1 1

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