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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)
2020 2021 2022 2023 2024 2025
2 1 3 1 4 1

MDR Year MDR Reports MDR Events
2020 189 189
2021 234 234
2022 281 281
2023 276 276
2024 263 268
2025 148 148

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 674 674
Patient Device Interaction Problem 150 150
Device Dislodged or Dislocated 141 141
Fracture 140 140
Loosening of Implant Not Related to Bone-Ingrowth 127 132
Insufficient Information 78 78
Material Integrity Problem 50 50
Mechanical Problem 37 37
Naturally Worn 31 31
Unintended Movement 30 30
Unstable 26 26
Appropriate Term/Code Not Available 25 25
Break 22 22
Migration 18 18
Manufacturing, Packaging or Shipping Problem 12 12
Use of Device Problem 12 12
Degraded 9 9
Malposition of Device 7 7
Noise, Audible 7 7
Packaging Problem 6 6
Tear, Rip or Hole in Device Packaging 6 6
No Apparent Adverse Event 6 6
Device Contaminated During Manufacture or Shipping 6 6
Delivered as Unsterile Product 4 4
Inadequacy of Device Shape and/or Size 4 4
Loose or Intermittent Connection 4 4
Biocompatibility 4 4
Scratched Material 3 3
Off-Label Use 3 3
No Device Output 3 3
Patient-Device Incompatibility 2 2
Shipping Damage or Problem 2 2
Problem with Sterilization 2 2
Failure to Osseointegrate 2 2
Difficult to Open or Remove Packaging Material 2 2
Migration or Expulsion of Device 2 2
Device Appears to Trigger Rejection 2 2
Improper or Incorrect Procedure or Method 2 2
Unsealed Device Packaging 1 1
Positioning Problem 1 1
Material Fragmentation 1 1
Output Problem 1 1
Structural Problem 1 1
Misassembly by Users 1 1
Labelling, Instructions for Use or Training Problem 1 1
Product Quality Problem 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 407 407
Insufficient Information 380 380
Failure of Implant 265 270
Joint Dislocation 126 126
No Clinical Signs, Symptoms or Conditions 91 91
Swelling/ Edema 63 63
No Information 62 62
Loss of Range of Motion 47 47
Unspecified Infection 40 40
Arthritis 33 33
Ambulation Difficulties 31 31
Bone Fracture(s) 31 31
No Known Impact Or Consequence To Patient 27 27
Joint Laxity 21 21
Fall 19 19
Swelling 19 19
Synovitis 17 17
No Consequences Or Impact To Patient 16 16
Metal Related Pathology 14 14
Edema 14 14
Discomfort 12 12
Osteolysis 11 11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 10 10
Hypersensitivity/Allergic reaction 10 10
Osteopenia/ Osteoporosis 10 10
Cramp(s) /Muscle Spasm(s) 10 10
Damage to Ligament(s) 9 9
Scar Tissue 9 9
Foreign Body In Patient 9 9
No Code Available 8 8
Cyst(s) 8 8
Hematoma 7 7
Post Operative Wound Infection 7 7
Tissue Breakdown 6 6
Hemorrhage/Bleeding 6 6
Joint Swelling 6 6
Inadequate Osseointegration 6 6
Wound Dehiscence 6 6
Death 6 6
Implant Pain 4 4
Skin Inflammation/ Irritation 4 4
Hyperextension 4 4
Subluxation 4 4
Fatigue 4 4
Loss of Vision 4 4
No Patient Involvement 3 3
Rash 3 3
Cellulitis 3 3
Inflammation 3 3
Muscle/Tendon Damage 3 3

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