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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 13

MDR Year MDR Reports MDR Events
2018 1265 1265
2019 1968 1968
2020 1864 1864
2021 2644 2644
2022 2324 2324
2023 1381 1381

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 7045 7045
Loss of or Failure to Bond 2247 2247
Naturally Worn 493 493
Insufficient Information 345 345
Migration 331 331
Unintended Movement 212 212
Loose or Intermittent Connection 171 171
Appropriate Term/Code Not Available 151 151
Device Dislodged or Dislocated 147 147
Osseointegration Problem 139 139
Fracture 102 102
Loosening of Implant Not Related to Bone-Ingrowth 102 102
Device Contaminated During Manufacture or Shipping 93 93
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
Material Deformation 39 39
No Apparent Adverse Event 39 39
Difficult to Insert 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
Patient-Device Incompatibility 14 14
Difficult to Advance 13 13
Incorrect Measurement 12 12
Physical Resistance/Sticking 11 11
Device Damaged Prior to Use 10 10
Expiration Date Error 10 10
Packaging Problem 9 9
Improper or Incorrect Procedure or Method 9 9
Fitting Problem 9 9
Product Quality Problem 6 6
Difficult to Remove 6 6
Contamination /Decontamination Problem 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
Incomplete or Missing Packaging 3 3
Device Issue 3 3
Computer Software Problem 2 2
Material Integrity Problem 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Device Markings/Labelling Problem 2 2
Device Packaging Compromised 2 2
Device Contamination with Chemical or Other Material 2 2
Difficult to Open or Close 1 1
Detachment of Device or Device Component 1 1
Device Operates Differently Than Expected 1 1
Device Damaged by Another Device 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
Structural Problem 1 1
Defective Component 1 1
Component Missing 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 4553 4553
No Code Available 3698 3698
Unspecified Infection 2180 2180
Joint Laxity 1512 1512
Adhesion(s) 769 769
Insufficient Information 766 766
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 707 707
Loss of Range of Motion 522 522
Not Applicable 518 518
Swelling/ Edema 488 488
Muscular Rigidity 471 471
Edema 338 338
Synovitis 297 297
Fall 293 293
No Consequences Or Impact To Patient 283 283
Osteolysis 268 268
Discomfort 244 244
Limited Mobility Of The Implanted Joint 237 237
Ambulation Difficulties 214 214
Inadequate Osseointegration 214 214
No Clinical Signs, Symptoms or Conditions 198 198
Inflammation 172 172
Unspecified Tissue Injury 155 155
Bone Fracture(s) 144 144
Swelling 126 126
Injury 121 121
Wound Dehiscence 120 120
Joint Disorder 119 119
Joint Dislocation 108 108
Hypersensitivity/Allergic reaction 93 93
Unspecified Musculoskeletal problem 80 80
Hemorrhage/Bleeding 78 78
Foreign Body Reaction 74 74
Hematoma 59 59
Scar Tissue 58 58
Thrombosis/Thrombus 57 57
Fibrosis 54 54
Joint Contracture 50 50
Fatigue 50 50
Cyst(s) 50 50
Erythema 48 48
Necrosis 48 48
No Known Impact Or Consequence To Patient 46 46
Fluid Discharge 45 45
Pulmonary Embolism 41 41
Muscle/Tendon Damage 40 40
Impaired Healing 39 39
Tissue Damage 37 37
Fever 34 34
Sepsis 30 30
Abscess 28 28
Weakness 27 27
Scarring 26 26
Anemia 23 23
Thrombosis 22 22
Local Reaction 21 21
Ossification 19 19
Nerve Damage 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
Pocket Erosion 11 11
Numbness 10 10
Thromboembolism 9 9
Itching Sensation 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) 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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