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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)
2017 2018 2019 2020 2021 2022
21 27 30 28 18 18

MDR Year MDR Reports MDR Events
2017 1142 1142
2018 1265 1265
2019 1968 1968
2020 1864 1864
2021 2648 2648
2022 1324 1324

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5284 5284
Loss of or Failure to Bond 2277 2277
Insufficient Information 872 872
Naturally Worn 423 423
Migration 284 284
Loose or Intermittent Connection 187 187
Appropriate Term/Code Not Available 178 178
Unintended Movement 169 169
Loss of Osseointegration 141 141
Device Dislodged or Dislocated 122 122
Migration or Expulsion of Device 120 120
Fracture 102 102
Loosening of Implant Not Related to Bone-Ingrowth 102 102
Malposition of Device 85 85
Break 82 82
Osseointegration Problem 81 81
Device Contaminated During Manufacture or Shipping 74 74
Noise, Audible 66 66
Use of Device Problem 63 63
Difficult to Open or Remove Packaging Material 60 60
Off-Label Use 57 57
Material Deformation 39 39
Material Twisted/Bent 32 32
Device-Device Incompatibility 32 32
Tear, Rip or Hole in Device Packaging 30 30
Inadequacy of Device Shape and/or Size 30 30
Difficult to Insert 30 30
Unstable 29 29
Failure To Adhere Or Bond 25 25
Mechanical Jam 19 19
Patient Device Interaction Problem 14 14
Difficult to Advance 13 13
Patient-Device Incompatibility 12 12
Incorrect Measurement 12 12
Physical Resistance/Sticking 11 11
No Apparent Adverse Event 11 11
Fitting Problem 10 10
Disassembly 9 9
Packaging Problem 9 9
Device Damaged Prior to Use 7 7
Difficult to Remove 7 7
Product Quality Problem 6 6
Improper or Incorrect Procedure or Method 6 6
Contamination /Decontamination Problem 6 6
Expiration Date Error 5 5
Defective Device 5 5
Delivered as Unsterile Product 5 5
Scratched Material 4 4
Inaccurate Information 4 4
Missing Information 4 4
Illegible Information 3 3
Crack 3 3
Device Issue 3 3
Device Disinfection Or Sterilization Issue 3 3
Biocompatibility 3 3
Device Packaging Compromised 3 3
Device Contamination with Chemical or Other Material 2 2
Material Integrity Problem 2 2
Device Markings/Labelling Problem 2 2
Device Operates Differently Than Expected 2 2
Ambient Noise Problem 2 2
Incomplete or Missing Packaging 2 2
Entrapment of Device 2 2
Computer Software Problem 2 2
Corroded 2 2
Material Separation 2 2
Shipping Damage or Problem 1 1
Material Too Rigid or Stiff 1 1
Failure to Osseointegrate 1 1
Defective Component 1 1
Component Missing 1 1
Material Erosion 1 1
Unsealed Device Packaging 1 1
Pitted 1 1
Misconnection 1 1
Nonstandard Device 1 1
Material Fragmentation 1 1
Overfill 1 1
Structural Problem 1 1
Connection Problem 1 1
Detachment of Device or Device Component 1 1
Device Damaged by Another Device 1 1
Positioning Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Difficult to Open or Close 1 1
Separation Problem 1 1
Device Difficult to Maintain 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 4328 4328
No Code Available 3854 3854
Unspecified Infection 1686 1686
Joint Laxity 1016 1016
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 708 708
Adhesion(s) 668 668
Not Applicable 521 521
Insufficient Information 431 431
Loss of Range of Motion 425 425
Muscular Rigidity 366 366
Swelling/ Edema 348 348
Edema 343 343
No Consequences Or Impact To Patient 314 314
Osteolysis 291 291
No Information 271 271
Synovitis 255 255
Limited Mobility Of The Implanted Joint 249 249
Discomfort 243 243
Fall 225 225
Ambulation Difficulties 171 171
Inadequate Osseointegration 158 158
Inflammation 156 156
Swelling 146 146
Bone Fracture(s) 138 138
Joint Disorder 132 132
Injury 128 128
No Clinical Signs, Symptoms or Conditions 121 121
Wound Dehiscence 103 103
Joint Dislocation 91 91
Hypersensitivity/Allergic reaction 84 84
Foreign Body Reaction 64 64
Unspecified Tissue Injury 63 63
No Known Impact Or Consequence To Patient 61 61
Scar Tissue 57 57
Hematoma 56 56
Hemorrhage/Bleeding 56 56
Fibrosis 55 55
Cyst(s) 47 47
Tissue Damage 47 47
Necrosis 46 46
Fatigue 39 39
Thrombosis/Thrombus 39 39
Fluid Discharge 37 37
Muscle/Tendon Damage 36 36
Erythema 34 34
Impaired Healing 33 33
Unspecified Musculoskeletal problem 32 32
Pulmonary Embolism 32 32
Joint Contracture 29 29
Weakness 29 29
Fever 28 28
Scarring 27 27
Sepsis 26 26
Local Reaction 23 23
Thrombosis 22 22
Abscess 21 21
Anemia 20 20
Joint Swelling 18 18
Failure of Implant 16 16
Low Blood Pressure/ Hypotension 14 14
Rash 14 14
Cellulitis 14 14
Ossification 14 14
Post Operative Wound Infection 13 13
Deformity/ Disfigurement 12 12
Nerve Damage 12 12
Thromboembolism 10 10
Itching Sensation 9 9
Heart Failure 8 8
Numbness 8 8
Blood Loss 7 7
Hypoesthesia 7 7
Distress 7 7
Pocket Erosion 7 7
Perforation of Vessels 7 7
Limb Fracture 6 6
Pleural Effusion 5 5
Dyspnea 5 5
Ecchymosis 5 5
High Blood Pressure/ Hypertension 5 5
Stroke/CVA 5 5
Chest Pain 4 4
Purulent Discharge 4 4
Pyrosis/Heartburn 4 4
Headache 4 4
Irritation 4 4
Ischemia 4 4
Urinary Retention 4 4
Tinnitus 4 4
Unspecified Mental, Emotional or Behavioural Problem 4 4
Renal Impairment 4 4
Physical Asymmetry 4 4
Rupture 4 4
Anxiety 4 4
No Patient Involvement 4 4
Confusion/ Disorientation 3 3
Reaction 3 3
Burning Sensation 3 3
Chills 3 3
Dizziness 3 3

Recalls
Manufacturer Recall Class Date Posted
1 DePuy Orthopaedics, Inc. II Sep-01-2021
2 DePuy Orthopaedics, Inc. II Mar-29-2021
3 ZIMMER ORTHOPEDIC MFG LTD II Feb-21-2018
4 Zimmer Biomet, Inc. II Nov-07-2019
5 Zimmer Biomet, Inc. II Mar-14-2018
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