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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 0

MDR Year MDR Reports MDR Events
2017 676 676
2018 251 251
2019 518 518
2020 190 190
2021 230 230

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 766 766
Adverse Event Without Identified Device or Use Problem 276 276
Appropriate Term/Code Not Available 208 208
Device Dislodged or Dislocated 131 131
Migration or Expulsion of Device 78 78
Loose or Intermittent Connection 77 77
Fracture 76 76
Patient Device Interaction Problem 52 52
Break 49 49
Unstable 45 45
Material Integrity Problem 41 41
Loosening of Implant Not Related to Bone-Ingrowth 35 35
Mechanical Problem 33 33
Loss of or Failure to Bond 28 28
Unintended Movement 23 23
Noise, Audible 22 22
Migration 19 19
Malposition of Device 16 16
Packaging Problem 13 13
Manufacturing, Packaging or Shipping Problem 12 12
Naturally Worn 11 11
Material Erosion 8 8
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
Metal Shedding Debris 4 4
Fitting Problem 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
Degraded 2 2
Disassembly 2 2
Inaccurate Delivery 2 2
Improper or Incorrect Procedure or Method 2 2
Patient-Device Incompatibility 2 2
Problem with Sterilization 2 2
Use of Device Problem 2 2
Off-Label Use 2 2
Device Appears to Trigger Rejection 2 2
Material Rupture 1 1
Shipping Damage or Problem 1 1
Product Quality Problem 1 1
Deformation Due to Compressive Stress 1 1
Dull, Blunt 1 1
Structural 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 520 520
No Code Available 178 178
Joint Dislocation 117 117
Insufficient Information 90 90
Swelling 71 71
No Known Impact Or Consequence To Patient 70 70
Unspecified Infection 60 60
Bone Fracture(s) 57 57
Ambulation Difficulties 51 51
Arthritis 44 44
Death 41 41
No Consequences Or Impact To Patient 41 41
Loss of Range of Motion 37 37
No Clinical Signs, Symptoms or Conditions 33 33
Edema 19 19
Patient Problem/Medical Problem 18 18
Failure of Implant 16 16
No Patient Involvement 15 15
Sleep Dysfunction 13 13
Inflammation 12 12
Reaction 11 11
Synovitis 11 11
Hematoma 10 10
Swelling/ Edema 10 10
Damage to Ligament(s) 9 9
Discomfort 9 9
Collapse 8 8
Fall 8 8
Cyst(s) 7 7
Wound Dehiscence 7 7
Limited Mobility Of The Implanted Joint 7 7
Joint Swelling 7 7
Pulmonary Embolism 6 6
Aspiration/Inhalation 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Adhesion(s) 5 5
Necrosis 5 5
Osteolysis 5 5
Joint Disorder 4 4
Local Reaction 4 4
High Blood Pressure/ Hypertension 4 4
Fever 4 4
Hemorrhage/Bleeding 4 4
Scar Tissue 3 3
Injury 3 3
Overwear Syndrome 3 3
Seroma 3 3
Skin Irritation 3 3
Impaired Healing 3 3
Fungal Infection 3 3
Foreign Body In Patient 3 3
Post Operative Wound Infection 2 2
Blood Loss 2 2
Numbness 2 2
Tingling 2 2
Dizziness 2 2
Tissue Damage 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
Hypersensitivity/Allergic reaction 1 1
Seizures 1 1
Rash 1 1
Nerve Damage 1 1
Paresis 1 1
Visual Disturbances 1 1
Deformity/ Disfigurement 1 1
Tissue Breakdown 1 1
Thromboembolism 1 1

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