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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)
2020 2021 2022 2023 2024 2025
28 18 30 17 23 18

MDR Year MDR Reports MDR Events
2020 1864 1865
2021 2644 2644
2022 2322 2325
2023 1593 1593
2024 1236 1236
2025 912 912

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 7661 7662
Loss of or Failure to Bond 1443 1443
Naturally Worn 469 469
Migration 271 271
Osseointegration Problem 202 202
Unintended Movement 181 181
Device Dislodged or Dislocated 132 132
Device Contaminated During Manufacture or Shipping 105 105
Fracture 95 95
Difficult to Open or Remove Packaging Material 69 69
Use of Device Problem 62 62
Noise, Audible 55 55
Off-Label Use 53 53
Appropriate Term/Code Not Available 45 45
Tear, Rip or Hole in Device Packaging 43 43
Difficult to Insert 35 35
No Apparent Adverse Event 31 31
Loss of Osseointegration 29 29
Material Deformation 27 27
Loosening of Implant Not Related to Bone-Ingrowth 25 28
Device-Device Incompatibility 20 20
Break 20 20
Insufficient Information 17 17
Patient Device Interaction Problem 17 17
Malposition of Device 16 16
Improper or Incorrect Procedure or Method 14 14
Material Twisted/Bent 14 14
Device Damaged Prior to Use 12 12
Inadequacy of Device Shape and/or Size 12 12
Difficult to Advance 11 11
Incorrect Measurement 10 10
Expiration Date Error 10 10
Patient-Device Incompatibility 10 10
Mechanical Jam 8 8
Contamination /Decontamination Problem 6 6
Inaccurate Information 6 6
Unstable 5 5
Illegible Information 4 4
Migration or Expulsion of Device 4 4
Missing Information 3 3
Corroded 3 3
Physical Resistance/Sticking 3 3
Incomplete or Missing Packaging 3 3
Degraded 2 2
Scratched Material 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Defective Device 2 2
Computer Software Problem 2 2
Device Markings/Labelling Problem 2 2
Difficult to Remove 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 3557 3561
Unspecified Infection 2422 2422
Joint Laxity 1901 1901
No Code Available 1597 1597
Insufficient Information 1092 1092
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 695 695
Adhesion(s) 679 679
Swelling/ Edema 542 545
Muscular Rigidity 521 521
Loss of Range of Motion 510 510
Fall 352 352
Synovitis 261 261
Unspecified Tissue Injury 237 237
No Clinical Signs, Symptoms or Conditions 230 230
Inadequate Osseointegration 225 225
Osteolysis 203 203
Discomfort 199 202
Ambulation Difficulties 193 196
Edema 175 175
Inflammation 151 151
Bone Fracture(s) 136 136
Limited Mobility Of The Implanted Joint 136 136
Wound Dehiscence 135 135
Joint Dislocation 112 112
Unspecified Musculoskeletal problem 89 89
Hemorrhage/Bleeding 83 83
Foreign Body Reaction 76 76
Hypersensitivity/Allergic reaction 68 68
No Consequences Or Impact To Patient 68 68
Fluid Discharge 61 61
Thrombosis/Thrombus 60 60
Joint Contracture 58 58
Erythema 50 50
Fatigue 49 49
Hematoma 48 48
Cyst(s) 45 45
Injury 45 45
Impaired Healing 44 44
Muscle/Tendon Damage 43 43
Scar Tissue 42 42
Pulmonary Embolism 40 40
Sepsis 36 36
Necrosis 36 36
Ossification 29 29
Fever 29 29
Fibrosis 28 28
Abscess 27 27
Anemia 19 19
Nerve Damage 19 19
Joint Disorder 18 18

Recalls
Manufacturer Recall Class Date Posted
1 DePuy Orthopaedics, Inc. II Sep-01-2021
2 DePuy Orthopaedics, Inc. II Mar-29-2021
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