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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)
2019 2020 2021 2022 2023 2024
12 2 1 3 1 0

MDR Year MDR Reports MDR Events
2019 518 518
2020 190 190
2021 234 234
2022 281 281
2023 276 276
2024 48 48

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 531 531
Insufficient Information 296 296
Patient Device Interaction Problem 151 151
Device Dislodged or Dislocated 133 133
Fracture 109 109
Loosening of Implant Not Related to Bone-Ingrowth 98 98
Appropriate Term/Code Not Available 92 92
Loose or Intermittent Connection 60 60
Break 50 50
Material Integrity Problem 50 50
Mechanical Problem 38 38
Unintended Movement 30 30
Migration 25 25
Unstable 21 21
Noise, Audible 14 14
Manufacturing, Packaging or Shipping Problem 12 12
Use of Device Problem 12 12
Naturally Worn 10 10
Malposition of Device 9 9
Degraded 9 9
Packaging Problem 8 8
Tear, Rip or Hole in Device Packaging 7 7
Delivered as Unsterile Product 4 4
Unsealed Device Packaging 4 4
No Device Output 3 3
Off-Label Use 3 3
Collapse 3 3
Device Markings/Labelling Problem 3 3
Difficult to Open or Remove Packaging Material 3 3
Fitting Problem 3 3
Missing Information 3 3
Material Twisted/Bent 3 3
Scratched Material 3 3
Mechanical Jam 2 2
Inaccurate Delivery 2 2
Inadequacy of Device Shape and/or Size 2 2
Problem with Sterilization 2 2
Failure to Osseointegrate 2 2
Improper or Incorrect Procedure or Method 2 2
Patient-Device Incompatibility 2 2
Biocompatibility 2 2
Device Appears to Trigger Rejection 2 2
Shipping Damage or Problem 1 1
Product Quality Problem 1 1
Pitted 1 1
Component Incompatible 1 1
Material Erosion 1 1
Migration or Expulsion of Device 1 1
Material Fragmentation 1 1
Labelling, Instructions for Use or Training Problem 1 1
Detachment of Device or Device Component 1 1
Structural Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Output Problem 1 1
Positioning Problem 1 1
Misassembly by Users 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 439 439
No Information 307 307
Insufficient Information 244 244
Failure of Implant 174 174
Joint Dislocation 130 130
No Code Available 75 75
No Clinical Signs, Symptoms or Conditions 72 72
Swelling/ Edema 60 60
No Known Impact Or Consequence To Patient 38 38
Unspecified Infection 38 38
Loss of Range of Motion 38 38
Bone Fracture(s) 38 38
Arthritis 33 33
No Consequences Or Impact To Patient 32 32
Swelling 31 31
Ambulation Difficulties 29 29
Edema 17 17
Synovitis 14 14
Damage to Ligament(s) 14 14
Fall 12 12
Cyst(s) 11 11
Metal Related Pathology 11 11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 10 10
Cramp(s) /Muscle Spasm(s) 10 10
Hypersensitivity/Allergic reaction 10 10
Wound Dehiscence 9 9
No Patient Involvement 9 9
Osteolysis 9 9
Joint Laxity 9 9
Osteopenia/ Osteoporosis 9 9
Discomfort 8 8
Hematoma 8 8
Scar Tissue 8 8
Inflammation 6 6
Hemorrhage/Bleeding 6 6
Death 6 6
Joint Swelling 6 6
Inadequate Osseointegration 6 6
Collapse 6 6
Tissue Breakdown 6 6
Foreign Body In Patient 5 5
Pulmonary Embolism 5 5
Fatigue 4 4
Fever 4 4
Loss of Vision 4 4
Skin Inflammation/ Irritation 4 4
Implant Pain 4 4
Muscle/Tendon Damage 3 3
Fungal Infection 3 3
Impaired Healing 3 3
Reaction 3 3
Deformity/ Disfigurement 3 3
Hyperextension 3 3
Overwear Syndrome 3 3
Seroma 3 3
Skin Irritation 3 3
Cellulitis 3 3
Necrosis 3 3
Rash 3 3
Local Reaction 3 3
High Blood Pressure/ Hypertension 3 3
Aspiration/Inhalation 3 3
Erosion 1 1
Abdominal Pain 1 1
Adhesion(s) 1 1
Muscle Weakness 1 1
Subluxation 1 1
Post Operative Wound Infection 1 1
Sleep Dysfunction 1 1

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