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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Definition This type of device is designed to allow for motion between the plastic bearing and metal baseplate components of a knee prosthesis. It is intended to replace a knee joint in order to relieve pain and restore knee function, for indications such as osteoarthritis, inflammatory arthritis, traumatic arthritis, and revision of failed knee prostheses.
Product CodeNJL
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
12 4 8 11 15 21 23 17 21 27 30 28 18 30 17 7

MDR Year MDR Reports MDR Events
2014 1299 1299
2015 1067 1067
2016 1387 1387
2017 1142 1142
2018 1265 1265
2019 1968 1968
2020 1864 1864
2021 2644 2644
2022 2324 2324
2023 1593 1593
2024 472 472

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 7589 7589
Loss of or Failure to Bond 3520 3520
Insufficient Information 2891 2891
Naturally Worn 812 812
Migration 357 357
Migration or Expulsion of Device 329 329
Loss of Osseointegration 294 294
Appropriate Term/Code Not Available 260 260
Unintended Movement 218 218
Loose or Intermittent Connection 196 196
Device Dislodged or Dislocated 172 172
Break 164 164
Fracture 163 163
Osseointegration Problem 154 154
Malposition of Device 142 142
Noise, Audible 107 107
Loosening of Implant Not Related to Bone-Ingrowth 103 103
Device Contaminated During Manufacture or Shipping 100 100
Use of Device Problem 79 79
Inadequacy of Device Shape and/or Size 71 71
Difficult to Open or Remove Packaging Material 70 70
Off-Label Use 64 64
Failure To Adhere Or Bond 63 63
Unstable 44 44
Tear, Rip or Hole in Device Packaging 43 43
Difficult to Insert 40 40
No Apparent Adverse Event 40 40
Material Deformation 39 39
Device-Device Incompatibility 38 38
Material Twisted/Bent 32 32
Disassembly 29 29
Mechanical Jam 20 20
Patient Device Interaction Problem 20 20
Patient-Device Incompatibility 18 18
Metal Shedding Debris 17 17
Incorrect Measurement 16 16
Device Slipped 14 14
Device Contamination with Chemical or Other Material 14 14
Difficult to Advance 13 13
Fitting Problem 13 13
Device Damaged Prior to Use 11 11
Improper or Incorrect Procedure or Method 11 11
Physical Resistance/Sticking 11 11
Packaging Problem 10 10
Expiration Date Error 10 10
Difficult to Remove 7 7
Scratched Material 7 7
Inaccurate Information 6 6
Product Quality Problem 6 6
Nonstandard Device 6 6
Delivered as Unsterile Product 6 6
Corroded 6 6
Defective Device 6 6
Contamination /Decontamination Problem 6 6
Incomplete or Missing Packaging 5 5
Device Operates Differently Than Expected 5 5
Device Packaging Compromised 4 4
Crack 4 4
Material Separation 4 4
Missing Information 4 4
Illegible Information 4 4
Unsealed Device Packaging 3 3
Entrapment of Device 3 3
Component Incompatible 3 3
Delamination 3 3
Device Disinfection Or Sterilization Issue 3 3
Device Issue 3 3
Biocompatibility 3 3
Component Missing 2 2
Ambient Noise Problem 2 2
Device Markings/Labelling Problem 2 2
Material Integrity Problem 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Computer Software Problem 2 2
Complete Blockage 1 1
Material Erosion 1 1
Misconnection 1 1
Material Fragmentation 1 1
Pitted 1 1
Material Too Rigid or Stiff 1 1
Material Rupture 1 1
Shipping Damage or Problem 1 1
Failure to Osseointegrate 1 1
Detachment of Device or Device Component 1 1
Device Damaged by Another Device 1 1
Difficult to Open or Close 1 1
Connection Problem 1 1
Defective Component 1 1
Overfill 1 1
Structural Problem 1 1
Separation Problem 1 1
Mechanics Altered 1 1
Positioning Problem 1 1
Device Difficult to Maintain 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 7134 7134
No Code Available 4156 4156
Unspecified Infection 3290 3290
Joint Laxity 1667 1667
No Information 1216 1216
Insufficient Information 849 849
Adhesion(s) 805 805
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 711 711
Loss of Range of Motion 620 620
Osteolysis 569 569
Not Applicable 522 522
Swelling/ Edema 519 519
Muscular Rigidity 513 513
Edema 352 352
Fall 352 352
Synovitis 351 351
No Consequences Or Impact To Patient 318 318
Discomfort 317 317
Limited Mobility Of The Implanted Joint 257 257
Bone Fracture(s) 234 234
Inadequate Osseointegration 230 230
Ambulation Difficulties 227 227
Inflammation 212 212
No Clinical Signs, Symptoms or Conditions 211 211
Unspecified Tissue Injury 183 183
Swelling 175 175
Foreign Body Reaction 139 139
Joint Disorder 133 133
Injury 129 129
Wound Dehiscence 127 127
Joint Dislocation 122 122
Hypersensitivity/Allergic reaction 111 111
No Known Impact Or Consequence To Patient 107 107
Unspecified Musculoskeletal problem 85 85
Hemorrhage/Bleeding 80 80
Joint Swelling 71 71
Scar Tissue 63 63
Hematoma 60 60
Cyst(s) 59 59
Fibrosis 58 58
Thrombosis/Thrombus 57 57
Fatigue 52 52
Joint Contracture 51 51
Necrosis 50 50
Erythema 49 49
Tissue Damage 49 49
Fluid Discharge 48 48
Muscle/Tendon Damage 42 42
Pulmonary Embolism 41 41
Impaired Healing 39 39
Fever 35 35
Sepsis 33 33
Failure of Implant 29 29
Weakness 29 29
Abscess 28 28
Scarring 27 27
Ossification 24 24
Anemia 23 23
Local Reaction 23 23
Thrombosis 22 22
Rash 20 20
Nerve Damage 20 20
Host-Tissue Reaction 19 19
Cellulitis 16 16
Irritation 16 16
Post Operative Wound Infection 16 16
Deformity/ Disfigurement 15 15
Low Blood Pressure/ Hypotension 14 14
Thromboembolism 12 12
Numbness 12 12
Physical Asymmetry 12 12
Itching Sensation 11 11
Pocket Erosion 11 11
Arrhythmia 9 9
Bacterial Infection 8 8
Dizziness 8 8
Heart Failure 8 8
Perforation of Vessels 7 7
Hypoesthesia 7 7
Distress 7 7
Reaction 7 7
Blood Loss 7 7
Limb Fracture 7 7
Stroke/CVA 7 7
Pneumonia 7 7
Myocardial Infarction 7 7
Chest Pain 6 6
Heart Failure/Congestive Heart Failure 6 6
Urinary Tract Infection 6 6
Burning Sensation 5 5
Dyspnea 5 5
Ecchymosis 5 5
High Blood Pressure/ Hypertension 5 5
Pleural Effusion 5 5
Ischemia 4 4
Nausea 4 4
Purulent Discharge 4 4
Pyrosis/Heartburn 4 4
Headache 4 4
Rupture 4 4

Recalls
Manufacturer Recall Class Date Posted
1 DePuy Orthopaedics, Inc. II Sep-01-2021
2 DePuy Orthopaedics, Inc. II Mar-29-2021
3 DePuy Orthopaedics, Inc. II Dec-03-2016
4 DePuy Orthopaedics, Inc. II May-26-2015
5 Exactech, Inc. II Jul-24-2012
6 ZIMMER ORTHOPEDIC MFG LTD II Feb-21-2018
7 Zimmer Biomet, Inc. II Nov-07-2019
8 Zimmer Biomet, Inc. II Mar-14-2018
9 Zimmer Biomet, Inc. II Feb-22-2016
10 Zimmer Inc. II Jun-25-2009
11 Zimmer, Inc. II Oct-25-2013
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