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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 1

MDR Year MDR Reports MDR Events
2016 1387 1387
2017 1142 1142
2018 1265 1265
2019 1964 1964
2020 1860 1860
2021 708 708

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2898 2898
Loss of or Failure to Bond 2239 2239
Insufficient Information 1573 1573
Naturally Worn 348 348
Migration or Expulsion of Device 204 204
Migration 204 204
Loss of Osseointegration 190 190
Loose or Intermittent Connection 189 189
Appropriate Term/Code Not Available 171 171
Break 126 126
Unintended Movement 123 123
Malposition of Device 104 104
Loosening of Implant Not Related to Bone-Ingrowth 99 99
Fracture 87 87
Device Dislodged or Dislocated 84 84
Noise, Audible 59 59
Inadequacy of Device Shape and/or Size 45 45
Use of Device Problem 44 44
Material Deformation 39 39
Failure To Adhere Or Bond 36 36
Material Twisted/Bent 32 32
Unstable 31 31
Device-Device Incompatibility 29 29
Osseointegration Problem 21 21
Mechanical Jam 19 19
Disassembly 18 18
Tear, Rip or Hole in Device Packaging 17 17
Device Contaminated During Manufacture or Shipping 16 16
Off-Label Use 15 15
Device Contamination with Chemical or Other Material 14 14
Difficult to Insert 13 13
Fitting Problem 11 11
Difficult to Open or Remove Packaging Material 11 11
Physical Resistance/Sticking 11 11
No Apparent Adverse Event 10 10
Packaging Problem 9 9
Patient Device Interaction Problem 9 9
Incorrect Measurement 9 9
Patient-Device Incompatibility 8 8
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 Slipped 5 5
Device Packaging Compromised 4 4
Crack 4 4
Material Separation 4 4
Device Damaged Prior to Use 4 4
Corroded 3 3
Difficult to Advance 3 3
Device Disinfection Or Sterilization Issue 3 3
Device Operates Differently Than Expected 3 3
Device Issue 3 3
Biocompatibility 3 3
Expiration Date Error 3 3
Defective Device 3 3
Illegible Information 3 3
Missing Information 3 3
Ambient Noise Problem 2 2
Incomplete or Missing Packaging 2 2
Material Integrity Problem 2 2
Entrapment of Device 2 2
Metal Shedding Debris 2 2
Failure to Osseointegrate 1 1
Improper or Incorrect Procedure or Method 1 1
Defective Component 1 1
Component Missing 1 1
Shipping Damage or Problem 1 1
Material Too Rigid or Stiff 1 1
Misconnection 1 1
Material Fragmentation 1 1
Component Incompatible 1 1
Unsealed Device Packaging 1 1
Pitted 1 1
Mechanics Altered 1 1
Device Damaged by Another Device 1 1
Device Markings/Labelling Problem 1 1
Difficult to Open or Close 1 1
Overfill 1 1
Structural Problem 1 1
Connection Problem 1 1
Delamination 1 1
Inaccurate Information 1 1
Separation Problem 1 1
Device Difficult to Maintain 1 1
Positioning Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 3980 3980
Pain 3770 3770
Unspecified Infection 1421 1421
No Information 612 612
Not Applicable 522 522
Adhesion(s) 420 420
Edema 343 343
No Consequences Or Impact To Patient 315 315
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 272 272
Osteolysis 269 269
Limited Mobility Of The Implanted Joint 255 255
Joint Laxity 223 223
Discomfort 186 186
Muscular Rigidity 177 177
Loss of Range of Motion 175 175
Swelling 168 168
Synovitis 150 150
Joint Disorder 133 133
Injury 128 128
Fall 125 125
Inflammation 115 115
Bone Fracture(s) 115 115
No Known Impact Or Consequence To Patient 102 102
Insufficient Information 101 101
Inadequate Osseointegration 98 98
Ambulation Difficulties 94 94
Swelling/ Edema 79 79
Hypersensitivity/Allergic reaction 64 64
Joint Dislocation 63 63
Foreign Body Reaction 55 55
Wound Dehiscence 54 54
Tissue Damage 47 47
Joint Swelling 45 45
Fibrosis 38 38
Necrosis 31 31
Cyst(s) 31 31
Hematoma 29 29
Hemorrhage/Bleeding 29 29
Weakness 29 29
Scarring 27 27
Scar Tissue 24 24
Thrombosis 22 22
Pulmonary Embolism 21 21
Local Reaction 21 21
No Clinical Signs, Symptoms or Conditions 20 20
Anemia 18 18
Fatigue 15 15
Fever 15 15
Thrombosis/Thrombus 15 15
Abscess 14 14
Failure of Implant 14 14
Impaired Healing 14 14
Rash 13 13
Sepsis 13 13
Deformity/ Disfigurement 11 11
Irritation 10 10
Thromboembolism 10 10
Ossification 10 10
Cellulitis 10 10
Post Operative Wound Infection 9 9
Unspecified Tissue Injury 9 9
Erythema 9 9
Heart Failure 8 8
Bacterial Infection 8 8
Itching Sensation 8 8
Blood Loss 7 7
Reaction 7 7
Hypoesthesia 7 7
Numbness 6 6
Low Blood Pressure/ Hypotension 6 6
Perforation of Vessels 6 6
Joint Contracture 6 6
Pocket Erosion 6 6
Nerve Damage 6 6
Pleural Effusion 5 5
Distress 5 5
Dyspnea 5 5
Host-Tissue Reaction 5 5
Fluid Discharge 5 5
Rupture 4 4
Pyrosis/Heartburn 4 4
High Blood Pressure/ Hypertension 4 4
Tinnitus 4 4
No Patient Involvement 4 4
Anxiety 4 4
Headache 4 4
Chest Pain 4 4
Purulent Discharge 4 4
Laceration(s) 3 3
Myocardial Infarction 3 3
Pulmonary Edema 3 3
Burning Sensation 3 3
Skin Discoloration 3 3
Renal Impairment 2 2
Muscle/Tendon Damage 2 2
Physical Asymmetry 2 2
Unspecified Mental, Emotional or Behavioural Problem 2 2
Calcium Deposits/Calcification 2 2
Hearing Impairment 2 2
Depression 2 2

Recalls
Manufacturer Recall Class Date Posted
1 DePuy Orthopaedics, Inc. II Mar-29-2021
2 DePuy Orthopaedics, Inc. II Dec-03-2016
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
6 Zimmer Biomet, Inc. II Feb-22-2016
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