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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 29

MDR Year MDR Reports MDR Events
2017 1142 1142
2018 1265 1265
2019 1968 1968
2020 1864 1864
2021 2649 2649
2022 1977 1977

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5774 5774
Loss of or Failure to Bond 2341 2341
Insufficient Information 872 872
Naturally Worn 448 448
Migration 296 296
Loose or Intermittent Connection 187 187
Unintended Movement 182 182
Appropriate Term/Code Not Available 179 179
Loss of Osseointegration 141 141
Device Dislodged or Dislocated 129 129
Migration or Expulsion of Device 120 120
Fracture 109 109
Osseointegration Problem 105 105
Loosening of Implant Not Related to Bone-Ingrowth 103 103
Break 86 86
Malposition of Device 85 85
Device Contaminated During Manufacture or Shipping 78 78
Difficult to Open or Remove Packaging Material 68 68
Noise, Audible 67 67
Use of Device Problem 66 66
Off-Label Use 57 57
Material Deformation 39 39
Difficult to Insert 37 37
Tear, Rip or Hole in Device Packaging 34 34
Device-Device Incompatibility 33 33
Material Twisted/Bent 32 32
Inadequacy of Device Shape and/or Size 30 30
Unstable 29 29
Failure To Adhere Or Bond 25 25
Mechanical Jam 19 19
Patient Device Interaction Problem 17 17
Difficult to Advance 13 13
Patient-Device Incompatibility 12 12
Incorrect Measurement 12 12
No Apparent Adverse Event 12 12
Physical Resistance/Sticking 11 11
Fitting Problem 10 10
Device Damaged Prior to Use 10 10
Disassembly 9 9
Packaging Problem 9 9
Difficult to Remove 7 7
Product Quality Problem 6 6
Improper or Incorrect Procedure or Method 6 6
Contamination /Decontamination Problem 6 6
Inaccurate Information 6 6
Expiration Date Error 5 5
Defective Device 5 5
Delivered as Unsterile Product 5 5
Missing Information 4 4
Illegible Information 4 4
Scratched Material 4 4
Entrapment of Device 3 3
Crack 3 3
Device Issue 3 3
Device Disinfection Or Sterilization Issue 3 3
Biocompatibility 3 3
Device Packaging Compromised 3 3
Manufacturing, Packaging or Shipping Problem 2 2
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
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
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 4518 4518
No Code Available 3854 3854
Unspecified Infection 1890 1890
Joint Laxity 1152 1152
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 708 708
Adhesion(s) 702 702
Insufficient Information 524 524
Not Applicable 521 521
Loss of Range of Motion 445 445
Muscular Rigidity 402 402
Swelling/ Edema 390 390
Edema 343 343
No Consequences Or Impact To Patient 314 314
Osteolysis 306 306
Synovitis 274 274
No Information 271 271
Discomfort 250 250
Limited Mobility Of The Implanted Joint 249 249
Fall 246 246
Inadequate Osseointegration 182 182
Ambulation Difficulties 179 179
Inflammation 165 165
Bone Fracture(s) 150 150
No Clinical Signs, Symptoms or Conditions 148 148
Swelling 146 146
Joint Disorder 132 132
Injury 128 128
Wound Dehiscence 116 116
Unspecified Tissue Injury 93 93
Joint Dislocation 92 92
Hypersensitivity/Allergic reaction 84 84
Foreign Body Reaction 67 67
No Known Impact Or Consequence To Patient 61 61
Hematoma 59 59
Hemorrhage/Bleeding 59 59
Scar Tissue 59 59
Fibrosis 57 57
Cyst(s) 50 50
Necrosis 48 48
Tissue Damage 47 47
Thrombosis/Thrombus 45 45
Fatigue 44 44
Fluid Discharge 42 42
Joint Contracture 40 40
Erythema 38 38
Unspecified Musculoskeletal problem 37 37
Muscle/Tendon Damage 36 36
Impaired Healing 33 33
Pulmonary Embolism 33 33
Fever 29 29
Weakness 29 29
Abscess 28 28
Scarring 27 27
Sepsis 26 26
Local Reaction 23 23
Thrombosis 22 22
Anemia 20 20
Joint Swelling 18 18
Failure of Implant 17 17
Post Operative Wound Infection 16 16
Low Blood Pressure/ Hypotension 14 14
Nerve Damage 14 14
Rash 14 14
Cellulitis 14 14
Ossification 14 14
Deformity/ Disfigurement 13 13
Thromboembolism 10 10
Pocket Erosion 10 10
Itching Sensation 9 9
Heart Failure 8 8
Numbness 8 8
Blood Loss 7 7
Hypoesthesia 7 7
Distress 7 7
Perforation of Vessels 7 7
Limb Fracture 6 6
Physical Asymmetry 5 5
Pleural Effusion 5 5
Pneumonia 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
Arrhythmia 4 4
Pyrosis/Heartburn 4 4
Headache 4 4
Irritation 4 4
Ischemia 4 4
Urinary Retention 4 4
Urinary Tract Infection 4 4
Tinnitus 4 4
Unspecified Mental, Emotional or Behavioural Problem 4 4
Renal Impairment 4 4
Rupture 4 4
Anxiety 4 4
No Patient Involvement 4 4
Confusion/ Disorientation 3 3
Reaction 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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