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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)
2017 2018 2019 2020 2021 2022
8 14 12 2 1 2

MDR Year MDR Reports MDR Events
2017 676 676
2018 251 251
2019 518 518
2020 190 190
2021 234 234
2022 197 197

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 769 769
Adverse Event Without Identified Device or Use Problem 368 368
Appropriate Term/Code Not Available 209 209
Device Dislodged or Dislocated 150 150
Patient Device Interaction Problem 104 104
Fracture 90 90
Migration or Expulsion of Device 78 78
Loose or Intermittent Connection 77 77
Break 56 56
Unstable 55 55
Material Integrity Problem 50 50
Loosening of Implant Not Related to Bone-Ingrowth 48 48
Mechanical Problem 44 44
Unintended Movement 31 31
Loss of or Failure to Bond 28 28
Noise, Audible 22 22
Migration 21 21
Malposition of Device 16 16
Packaging Problem 13 13
Manufacturing, Packaging or Shipping Problem 12 12
Naturally Worn 11 11
Use of Device Problem 10 10
Material Erosion 9 9
Tear, Rip or Hole in Device Packaging 7 7
Inadequacy of Device Shape and/or Size 6 6
Collapse 6 6
Unsealed Device Packaging 5 5
Device Markings/Labelling Problem 5 5
Device Packaging Compromised 4 4
Delivered as Unsterile Product 4 4
Fitting Problem 4 4
Metal Shedding Debris 4 4
No Device Output 3 3
Device-Device Incompatibility 3 3
Difficult to Open or Remove Packaging Material 3 3
Material Twisted/Bent 3 3
Missing Information 3 3
Mechanical Jam 2 2
Detachment of Device or Device Component 2 2
Degraded 2 2
Disassembly 2 2
Improper or Incorrect Procedure or Method 2 2
Off-Label Use 2 2
Device Appears to Trigger Rejection 2 2
Inaccurate Delivery 2 2
Problem with Sterilization 2 2
Patient-Device Incompatibility 2 2
Deformation Due to Compressive Stress 1 1
Dull, Blunt 1 1
Structural Problem 1 1
Material Rupture 1 1
Shipping Damage or Problem 1 1
Product Quality Problem 1 1
Detachment Of Device Component 1 1
Component Incompatible 1 1
Pitted 1 1
Labelling, Instructions for Use or Training Problem 1 1
Inadequate Instructions for Healthcare Professional 1 1
Device Contamination with Chemical or Other Material 1 1
Device Operates Differently Than Expected 1 1
Output Problem 1 1
Positioning Problem 1 1
Misassembly by Users 1 1
No Apparent Adverse Event 1 1
Device Handling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 612 612
Pain 574 574
No Code Available 178 178
Joint Dislocation 130 130
Insufficient Information 127 127
Unspecified Infection 83 83
Swelling 71 71
No Known Impact Or Consequence To Patient 70 70
Bone Fracture(s) 61 61
Failure of Implant 60 60
Ambulation Difficulties 51 51
Arthritis 45 45
No Clinical Signs, Symptoms or Conditions 44 44
Death 41 41
Loss of Range of Motion 41 41
No Consequences Or Impact To Patient 41 41
Swelling/ Edema 20 20
Edema 19 19
Damage to Ligament(s) 18 18
Patient Problem/Medical Problem 18 18
No Patient Involvement 15 15
Synovitis 14 14
Sleep Dysfunction 13 13
Hematoma 13 13
Wound Dehiscence 13 13
Inflammation 12 12
Fall 11 11
Reaction 11 11
Discomfort 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 9
Collapse 8 8
Limited Mobility Of The Implanted Joint 7 7
Joint Swelling 7 7
Cyst(s) 7 7
Hemorrhage/Bleeding 7 7
Pulmonary Embolism 6 6
Adhesion(s) 6 6
Aspiration/Inhalation 6 6
Necrosis 5 5
Osteolysis 5 5
Joint Disorder 4 4
Local Reaction 4 4
Fever 4 4
Hypersensitivity/Allergic reaction 4 4
High Blood Pressure/ Hypertension 4 4
Foreign Body In Patient 4 4
Implant Pain 4 4
Scar Tissue 3 3
Fungal Infection 3 3
Hyperextension 3 3
Joint Laxity 3 3
Impaired Healing 3 3
Injury 3 3
Overwear Syndrome 3 3
Seroma 3 3
Skin Irritation 3 3
Tingling 2 2
Dizziness 2 2
Tissue Damage 2 2
Post Operative Wound Infection 2 2
Numbness 2 2
Blood Loss 2 2
Muscular Rigidity 2 2
Debris, Bone Shedding 2 2
Bruise/Contusion 2 2
Abdominal Pain 2 2
Angina 1 1
Atrial Fibrillation 1 1
Bacterial Infection 1 1
Erosion 1 1
Chest Pain 1 1
Seizures 1 1
Rash 1 1
Nerve Damage 1 1
Paresis 1 1
Tissue Breakdown 1 1
Osteopenia/ Osteoporosis 1 1
Thromboembolism 1 1
Visual Disturbances 1 1
Deformity/ Disfigurement 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biomet U.K., Ltd. II Feb-22-2017
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