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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 1591 1591
2024 347 347

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 7487 7487
Loss of or Failure to Bond 3511 3511
Insufficient Information 2891 2891
Naturally Worn 805 805
Migration 353 353
Migration or Expulsion of Device 329 329
Loss of Osseointegration 294 294
Appropriate Term/Code Not Available 260 260
Unintended Movement 216 216
Loose or Intermittent Connection 196 196
Device Dislodged or Dislocated 171 171
Break 164 164
Fracture 161 161
Osseointegration Problem 150 150
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 76 76
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 7093 7093
No Code Available 4156 4156
Unspecified Infection 3259 3259
Joint Laxity 1629 1629
No Information 1216 1216
Insufficient Information 833 833
Adhesion(s) 800 800
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 711 711
Loss of Range of Motion 613 613
Osteolysis 568 568
Not Applicable 522 522
Swelling/ Edema 515 515
Muscular Rigidity 508 508
Edema 352 352
Synovitis 350 350
Fall 348 348
No Consequences Or Impact To Patient 318 318
Discomfort 314 314
Limited Mobility Of The Implanted Joint 257 257
Bone Fracture(s) 233 233
Inadequate Osseointegration 227 227
Ambulation Difficulties 225 225
Inflammation 212 212
No Clinical Signs, Symptoms or Conditions 211 211
Unspecified Tissue Injury 177 177
Swelling 175 175
Foreign Body Reaction 134 134
Joint Disorder 133 133
Injury 129 129
Wound Dehiscence 126 126
Joint Dislocation 121 121
Hypersensitivity/Allergic reaction 111 111
No Known Impact Or Consequence To Patient 107 107
Unspecified Musculoskeletal problem 83 83
Hemorrhage/Bleeding 78 78
Joint Swelling 71 71
Scar Tissue 63 63
Hematoma 60 60
Fibrosis 58 58
Thrombosis/Thrombus 57 57
Cyst(s) 57 57
Fatigue 52 52
Joint Contracture 51 51
Necrosis 50 50
Erythema 49 49
Tissue Damage 49 49
Fluid Discharge 48 48
Pulmonary Embolism 41 41
Muscle/Tendon Damage 40 40
Impaired Healing 39 39
Fever 35 35
Sepsis 30 30
Failure of Implant 29 29
Weakness 29 29
Abscess 28 28
Scarring 27 27
Local Reaction 23 23
Anemia 23 23
Ossification 22 22
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
Itching Sensation 11 11
Pocket Erosion 11 11
Physical Asymmetry 10 10
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
Stroke/CVA 7 7
Pneumonia 7 7
Myocardial Infarction 7 7
Chest Pain 6 6
Limb Fracture 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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