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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)
2016 2017 2018 2019 2020 2021
17 21 27 30 28 16

MDR Year MDR Reports MDR Events
2016 1387 1387
2017 1142 1142
2018 1265 1265
2019 1968 1968
2020 1864 1864
2021 2264 2264

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3991 3991
Loss of or Failure to Bond 2481 2481
Insufficient Information 1574 1574
Naturally Worn 425 425
Migration 249 249
Migration or Expulsion of Device 204 204
Appropriate Term/Code Not Available 198 198
Loss of Osseointegration 191 191
Loose or Intermittent Connection 190 190
Unintended Movement 151 151
Break 129 129
Device Dislodged or Dislocated 107 107
Malposition of Device 105 105
Fracture 103 103
Loosening of Implant Not Related to Bone-Ingrowth 101 101
Noise, Audible 70 70
Use of Device Problem 53 53
Inadequacy of Device Shape and/or Size 47 47
Device Contaminated During Manufacture or Shipping 45 45
Osseointegration Problem 44 44
Off-Label Use 43 43
Difficult to Open or Remove Packaging Material 42 42
Material Deformation 39 39
Failure To Adhere Or Bond 36 36
Material Twisted/Bent 32 32
Unstable 31 31
Device-Device Incompatibility 30 30
Difficult to Insert 21 21
Mechanical Jam 19 19
Disassembly 18 18
Tear, Rip or Hole in Device Packaging 17 17
Device Contamination with Chemical or Other Material 14 14
Patient Device Interaction Problem 12 12
Physical Resistance/Sticking 11 11
Fitting Problem 11 11
Incorrect Measurement 11 11
No Apparent Adverse Event 10 10
Packaging Problem 9 9
Patient-Device Incompatibility 9 9
Difficult to Advance 7 7
Difficult to Remove 7 7
Product Quality Problem 6 6
Nonstandard Device 6 6
Delivered as Unsterile Product 6 6
Contamination /Decontamination Problem 6 6
Scratched Material 6 6
Device Damaged Prior to Use 5 5
Device Slipped 5 5
Material Separation 4 4
Crack 4 4
Device Packaging Compromised 4 4
Missing Information 4 4
Illegible Information 3 3
Inaccurate Information 3 3
Biocompatibility 3 3
Device Operates Differently Than Expected 3 3
Device Disinfection Or Sterilization Issue 3 3
Incomplete or Missing Packaging 3 3
Device Issue 3 3
Expiration Date Error 3 3
Defective Device 3 3
Corroded 3 3
Entrapment of Device 2 2
Computer Software Problem 2 2
Metal Shedding Debris 2 2
Device Markings/Labelling Problem 2 2
Ambient Noise Problem 2 2
Material Integrity Problem 2 2
Mechanics Altered 1 1
Difficult to Open or Close 1 1
Device Damaged by Another Device 1 1
Structural Problem 1 1
Connection Problem 1 1
Delamination 1 1
Detachment of Device or Device Component 1 1
Overfill 1 1
Defective Component 1 1
Component Missing 1 1
Failure to Osseointegrate 1 1
Improper or Incorrect Procedure or Method 1 1
Shipping Damage or Problem 1 1
Material Too Rigid or Stiff 1 1
Misconnection 1 1
Component Incompatible 1 1
Material Erosion 1 1
Unsealed Device Packaging 1 1
Pitted 1 1
Material Fragmentation 1 1
Separation Problem 1 1
Positioning Problem 1 1
Device Difficult to Maintain 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 4375 4375
No Code Available 3988 3988
Unspecified Infection 1504 1504
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 700 700
Joint Laxity 614 614
No Information 612 612
Adhesion(s) 589 589
Not Applicable 522 522
Edema 344 344
Osteolysis 319 319
Loss of Range of Motion 317 317
No Consequences Or Impact To Patient 315 315
Muscular Rigidity 269 269
Insufficient Information 262 262
Limited Mobility Of The Implanted Joint 255 255
Discomfort 227 227
Synovitis 213 213
Swelling/ Edema 203 203
Fall 193 193
Swelling 168 168
Bone Fracture(s) 140 140
Inflammation 139 139
Joint Disorder 133 133
Injury 129 129
Ambulation Difficulties 128 128
Inadequate Osseointegration 121 121
No Known Impact Or Consequence To Patient 102 102
Joint Dislocation 79 79
Wound Dehiscence 79 79
No Clinical Signs, Symptoms or Conditions 68 68
Hypersensitivity/Allergic reaction 67 67
Foreign Body Reaction 66 66
Tissue Damage 47 47
Joint Swelling 45 45
Hematoma 45 45
Cyst(s) 43 43
Fibrosis 43 43
Necrosis 42 42
Hemorrhage/Bleeding 38 38
Weakness 29 29
Fever 27 27
Scarring 27 27
Scar Tissue 26 26
Pulmonary Embolism 26 26
Thrombosis/Thrombus 26 26
Muscle/Tendon Damage 26 26
Local Reaction 23 23
Thrombosis 22 22
Fatigue 21 21
Joint Contracture 21 21
Impaired Healing 20 20
Sepsis 20 20
Erythema 18 18
Abscess 18 18
Anemia 18 18
Failure of Implant 16 16
Ossification 14 14
Rash 13 13
Fluid Discharge 13 13
Unspecified Tissue Injury 13 13
Cellulitis 12 12
Deformity/ Disfigurement 11 11
Thromboembolism 10 10
Irritation 10 10
Itching Sensation 9 9
Post Operative Wound Infection 9 9
Numbness 8 8
Heart Failure 8 8
Low Blood Pressure/ Hypotension 8 8
Bacterial Infection 8 8
Nerve Damage 7 7
Hypoesthesia 7 7
Perforation of Vessels 7 7
Blood Loss 7 7
Reaction 7 7
Pocket Erosion 6 6
Pleural Effusion 5 5
High Blood Pressure/ Hypertension 5 5
Host-Tissue Reaction 5 5
Dyspnea 5 5
Distress 5 5
Rupture 4 4
Anxiety 4 4
No Patient Involvement 4 4
Purulent Discharge 4 4
Headache 4 4
Pyrosis/Heartburn 4 4
Chest Pain 4 4
Tinnitus 4 4
Pulmonary Edema 3 3
Skin Discoloration 3 3
Neuropathy 3 3
Laceration(s) 3 3
Myocardial Infarction 3 3
Stroke/CVA 3 3
Burning Sensation 3 3
Chills 3 3
Limb Fracture 3 3
Unspecified Mental, Emotional or Behavioural Problem 2 2
Physical Asymmetry 2 2

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 ZIMMER ORTHOPEDIC MFG LTD II Feb-21-2018
5 Zimmer Biomet, Inc. II Nov-07-2019
6 Zimmer Biomet, Inc. II Mar-14-2018
7 Zimmer Biomet, Inc. II Feb-22-2016
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