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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)
2019 2020 2021 2022 2023 2024
30 28 18 30 17 10

MDR Year MDR Reports MDR Events
2019 1968 1968
2020 1864 1864
2021 2644 2644
2022 2324 2324
2023 1593 1593
2024 569 569

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 7405 7405
Loss of or Failure to Bond 1986 1986
Naturally Worn 464 464
Migration 315 315
Unintended Movement 215 215
Osseointegration Problem 152 152
Device Dislodged or Dislocated 143 143
Device Contaminated During Manufacture or Shipping 97 97
Fracture 95 95
Loosening of Implant Not Related to Bone-Ingrowth 78 78
Use of Device Problem 75 75
Difficult to Open or Remove Packaging Material 66 66
Loss of Osseointegration 62 62
Noise, Audible 57 57
Appropriate Term/Code Not Available 56 56
Off-Label Use 55 55
Malposition of Device 52 52
Break 42 42
Tear, Rip or Hole in Device Packaging 41 41
No Apparent Adverse Event 40 40
Difficult to Insert 39 39
Device-Device Incompatibility 34 34
Material Deformation 34 34
Material Twisted/Bent 28 28
Inadequacy of Device Shape and/or Size 24 24
Insufficient Information 22 22
Patient Device Interaction Problem 20 20
Patient-Device Incompatibility 16 16
Mechanical Jam 14 14
Difficult to Advance 13 13
Loose or Intermittent Connection 13 13
Incorrect Measurement 12 12
Migration or Expulsion of Device 11 11
Improper or Incorrect Procedure or Method 11 11
Physical Resistance/Sticking 11 11
Unstable 10 10
Device Damaged Prior to Use 10 10
Expiration Date Error 10 10
Contamination /Decontamination Problem 6 6
Inaccurate Information 6 6
Corroded 5 5
Product Quality Problem 4 4
Defective Device 4 4
Missing Information 4 4
Illegible Information 4 4
Packaging Problem 4 4
Scratched Material 3 3
Incomplete or Missing Packaging 3 3
Difficult to Remove 3 3
Crack 2 2
Entrapment of Device 2 2
Computer Software Problem 2 2
Fitting Problem 2 2
Biocompatibility 2 2
Device Markings/Labelling Problem 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Material Integrity Problem 2 2
Difficult to Open or Close 1 1
Positioning Problem 1 1
Device Difficult to Maintain 1 1
Separation Problem 1 1
Detachment of Device or Device Component 1 1
Structural Problem 1 1
Material Fragmentation 1 1
Material Erosion 1 1
Material Separation 1 1
Shipping Damage or Problem 1 1
Nonstandard Device 1 1
Delivered as Unsterile Product 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 4146 4146
No Code Available 3348 3348
Unspecified Infection 2183 2183
Joint Laxity 1684 1684
Insufficient Information 864 864
Adhesion(s) 780 780
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 704 704
Loss of Range of Motion 518 518
Swelling/ Edema 516 516
Muscular Rigidity 487 487
Fall 309 309
Edema 300 300
Synovitis 277 277
Discomfort 240 240
Osteolysis 229 229
Limited Mobility Of The Implanted Joint 219 219
No Clinical Signs, Symptoms or Conditions 210 210
Ambulation Difficulties 205 205
Inadequate Osseointegration 203 203
Unspecified Tissue Injury 183 183
Inflammation 163 163
No Consequences Or Impact To Patient 147 147
Bone Fracture(s) 142 142
Wound Dehiscence 125 125
Joint Dislocation 112 112
Injury 101 101
Hypersensitivity/Allergic reaction 95 95
Unspecified Musculoskeletal problem 85 85
Hemorrhage/Bleeding 82 82
Foreign Body Reaction 81 81
Joint Disorder 75 75
Swelling 70 70
Thrombosis/Thrombus 57 57
Hematoma 54 54
Scar Tissue 53 53
Cyst(s) 51 51
Joint Contracture 51 51
Fatigue 50 50
Fibrosis 49 49
Fluid Discharge 48 48
Erythema 48 48
Necrosis 45 45
Not Applicable 44 44
Muscle/Tendon Damage 42 42
Pulmonary Embolism 41 41
Impaired Healing 38 38
Fever 33 33
Sepsis 33 33
Abscess 28 28
Anemia 23 23
Tissue Damage 23 23
Weakness 22 22
Ossification 21 21
Thrombosis 20 20
Rash 20 20
Local Reaction 20 20
Nerve Damage 19 19
Scarring 19 19
Failure of Implant 15 15
Post Operative Wound Infection 15 15
Cellulitis 14 14
Low Blood Pressure/ Hypotension 14 14
Deformity/ Disfigurement 12 12
Physical Asymmetry 12 12
Itching Sensation 11 11
Pocket Erosion 11 11
Thromboembolism 9 9
Numbness 9 9
Dizziness 8 8
Heart Failure 8 8
Limb Fracture 7 7
Myocardial Infarction 7 7
Stroke/CVA 7 7
Chest Pain 6 6
Pneumonia 6 6
Urinary Tract Infection 6 6
Heart Failure/Congestive Heart Failure 6 6
Hypoesthesia 5 5
Pleural Effusion 5 5
High Blood Pressure/ Hypertension 5 5
Dyspnea 5 5
Ecchymosis 5 5
Pyrosis/Heartburn 4 4
Headache 4 4
Purulent Discharge 4 4
Arrhythmia 4 4
Nausea 4 4
Ischemia 4 4
Perforation of Vessels 4 4
Burning Sensation 4 4
Tinnitus 4 4
Urinary Retention 4 4
Anxiety 4 4
Distress 4 4
No Known Impact Or Consequence To Patient 4 4
Renal Impairment 4 4
Unspecified Mental, Emotional or Behavioural Problem 4 4
Cramp(s) /Muscle Spasm(s) 3 3
No Information 3 3
Confusion/ Disorientation 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 Biomet, Inc. II Nov-07-2019
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