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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)
2018 2019 2020 2021 2022 2023
27 30 28 18 30 9

MDR Year MDR Reports MDR Events
2018 1265 1265
2019 1968 1968
2020 1864 1864
2021 2644 2644
2022 2324 2324
2023 1151 1151

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 6870 6870
Loss of or Failure to Bond 2225 2225
Naturally Worn 481 481
Insufficient Information 345 345
Migration 327 327
Unintended Movement 209 209
Loose or Intermittent Connection 171 171
Appropriate Term/Code Not Available 151 151
Device Dislodged or Dislocated 140 140
Osseointegration Problem 133 133
Loosening of Implant Not Related to Bone-Ingrowth 102 102
Fracture 101 101
Device Contaminated During Manufacture or Shipping 91 91
Loss of Osseointegration 78 78
Use of Device Problem 71 71
Difficult to Open or Remove Packaging Material 68 68
Malposition of Device 65 65
Noise, Audible 61 61
Off-Label Use 57 57
Break 52 52
Migration or Expulsion of Device 48 48
Tear, Rip or Hole in Device Packaging 41 41
Difficult to Insert 39 39
Material Deformation 39 39
No Apparent Adverse Event 39 39
Device-Device Incompatibility 38 38
Material Twisted/Bent 32 32
Inadequacy of Device Shape and/or Size 25 25
Unstable 22 22
Failure To Adhere Or Bond 21 21
Mechanical Jam 17 17
Patient Device Interaction Problem 17 17
Difficult to Advance 13 13
Patient-Device Incompatibility 13 13
Incorrect Measurement 12 12
Physical Resistance/Sticking 11 11
Device Damaged Prior to Use 10 10
Improper or Incorrect Procedure or Method 9 9
Fitting Problem 9 9
Packaging Problem 9 9
Contamination /Decontamination Problem 6 6
Expiration Date Error 6 6
Product Quality Problem 6 6
Difficult to Remove 6 6
Inaccurate Information 6 6
Delivered as Unsterile Product 5 5
Corroded 5 5
Defective Device 4 4
Missing Information 4 4
Illegible Information 4 4
Biocompatibility 3 3
Device Disinfection Or Sterilization Issue 3 3
Scratched Material 3 3
Crack 3 3
Disassembly 3 3
Entrapment of Device 3 3
Device Issue 3 3
Computer Software Problem 2 2
Material Integrity Problem 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Device Markings/Labelling Problem 2 2
Device Packaging Compromised 2 2
Difficult to Open or Close 1 1
Device Operates Differently Than Expected 1 1
Device Damaged by Another Device 1 1
Detachment of Device or Device Component 1 1
Structural Problem 1 1
Device Difficult to Maintain 1 1
Positioning Problem 1 1
Material Fragmentation 1 1
Material Erosion 1 1
Unsealed Device Packaging 1 1
Nonstandard Device 1 1
Defective Component 1 1
Component Missing 1 1
Incomplete or Missing Packaging 1 1
Material Too Rigid or Stiff 1 1
Material Separation 1 1
Shipping Damage or Problem 1 1
Failure to Osseointegrate 1 1
Separation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 4493 4493
No Code Available 3698 3698
Unspecified Infection 2115 2115
Joint Laxity 1460 1460
Adhesion(s) 765 765
Insufficient Information 726 726
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 707 707
Not Applicable 518 518
Loss of Range of Motion 515 515
Swelling/ Edema 485 485
Muscular Rigidity 452 452
Edema 338 338
Synovitis 296 296
Fall 288 288
No Consequences Or Impact To Patient 283 283
Osteolysis 268 268
Discomfort 242 242
Limited Mobility Of The Implanted Joint 237 237
Ambulation Difficulties 215 215
Inadequate Osseointegration 208 208
No Clinical Signs, Symptoms or Conditions 192 192
Inflammation 167 167
Unspecified Tissue Injury 149 149
Bone Fracture(s) 145 145
Swelling 126 126
Injury 121 121
Joint Disorder 119 119
Wound Dehiscence 119 119
Joint Dislocation 101 101
Hypersensitivity/Allergic reaction 93 93
Unspecified Musculoskeletal problem 80 80
Hemorrhage/Bleeding 78 78
Foreign Body Reaction 74 74
Hematoma 59 59
Scar Tissue 57 57
Thrombosis/Thrombus 55 55
Fibrosis 54 54
Fatigue 50 50
Cyst(s) 50 50
Joint Contracture 49 49
Erythema 48 48
Necrosis 48 48
No Known Impact Or Consequence To Patient 46 46
Fluid Discharge 45 45
Muscle/Tendon Damage 40 40
Impaired Healing 39 39
Tissue Damage 37 37
Pulmonary Embolism 37 37
Fever 34 34
Sepsis 29 29
Abscess 28 28
Weakness 27 27
Scarring 26 26
Anemia 23 23
Thrombosis 22 22
Local Reaction 21 21
Nerve Damage 17 17
Ossification 17 17
Rash 16 16
Failure of Implant 16 16
Post Operative Wound Infection 16 16
No Information 14 14
Low Blood Pressure/ Hypotension 14 14
Cellulitis 14 14
Deformity/ Disfigurement 13 13
Numbness 10 10
Pocket Erosion 10 10
Itching Sensation 9 9
Thromboembolism 9 9
Physical Asymmetry 8 8
Dizziness 8 8
Heart Failure 8 8
Hypoesthesia 7 7
Myocardial Infarction 7 7
Pneumonia 7 7
Stroke/CVA 7 7
Chest Pain 6 6
Urinary Tract Infection 6 6
Limb Fracture 6 6
Heart Failure/Congestive Heart Failure 6 6
Distress 5 5
Pleural Effusion 5 5
Dyspnea 5 5
Ecchymosis 5 5
High Blood Pressure/ Hypertension 5 5
Pyrosis/Heartburn 4 4
Headache 4 4
Purulent Discharge 4 4
Arrhythmia 4 4
Ischemia 4 4
Perforation of Vessels 4 4
Urinary Retention 4 4
Tinnitus 4 4
Rupture 4 4
Anxiety 4 4
Burning Sensation 4 4
No Patient Involvement 4 4
Renal Impairment 4 4
Unspecified Mental, Emotional or Behavioural Problem 4 4
Cramp(s) /Muscle Spasm(s) 4 4

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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