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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)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
12 4 8 11 15 21 23 17 21 27 30 28 18 30 17 16

MDR Year MDR Reports MDR Events
2014 1299 1299
2015 1067 1067
2016 1387 1387
2017 1142 1142
2018 1265 1265
2019 1968 1968
2020 1864 1864
2021 2644 2644
2022 2324 2324
2023 1593 1593
2024 841 841

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 7861 7861
Loss of or Failure to Bond 3559 3559
Insufficient Information 2891 2891
Naturally Worn 827 827
Migration 371 371
Migration or Expulsion of Device 329 329
Loss of Osseointegration 294 294
Appropriate Term/Code Not Available 261 261
Unintended Movement 220 220
Loose or Intermittent Connection 196 196
Device Dislodged or Dislocated 178 178
Fracture 166 166
Break 164 164
Osseointegration Problem 164 164
Malposition of Device 142 142
Noise, Audible 107 107
Device Contaminated During Manufacture or Shipping 105 105
Loosening of Implant Not Related to Bone-Ingrowth 103 103
Use of Device Problem 83 83
Difficult to Open or Remove Packaging Material 74 74
Inadequacy of Device Shape and/or Size 72 72
Off-Label Use 64 64
Failure To Adhere Or Bond 63 63
Unstable 44 44
Tear, Rip or Hole in Device Packaging 43 43
No Apparent Adverse Event 41 41
Difficult to Insert 40 40
Material Deformation 39 39
Device-Device Incompatibility 38 38
Material Twisted/Bent 32 32
Disassembly 29 29
Patient-Device Incompatibility 21 21
Mechanical Jam 20 20
Patient Device Interaction Problem 20 20
Metal Shedding Debris 17 17
Incorrect Measurement 16 16
Device Contamination with Chemical or Other Material 14 14
Device Slipped 14 14
Fitting Problem 13 13
Device Damaged Prior to Use 13 13
Difficult to Advance 13 13
Physical Resistance/Sticking 11 11
Improper or Incorrect Procedure or Method 11 11
Expiration Date Error 10 10
Packaging Problem 10 10
Scratched Material 7 7
Difficult to Remove 7 7
Contamination /Decontamination Problem 6 6
Nonstandard Device 6 6
Inaccurate Information 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 7229 7229
No Code Available 4156 4156
Unspecified Infection 3413 3413
Joint Laxity 1720 1720
No Information 1216 1216
Insufficient Information 909 909
Adhesion(s) 813 813
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 711 711
Loss of Range of Motion 627 627
Osteolysis 574 574
Swelling/ Edema 529 529
Muscular Rigidity 524 524
Not Applicable 522 522
Fall 365 365
Synovitis 353 353
Edema 352 352
Discomfort 320 320
No Consequences Or Impact To Patient 318 318
Limited Mobility Of The Implanted Joint 257 257
Inadequate Osseointegration 241 241
Bone Fracture(s) 237 237
Ambulation Difficulties 229 229
No Clinical Signs, Symptoms or Conditions 219 219
Inflammation 215 215
Unspecified Tissue Injury 187 187
Swelling 175 175
Foreign Body Reaction 142 142
Joint Disorder 133 133
Wound Dehiscence 132 132
Injury 129 129
Joint Dislocation 126 126
Hypersensitivity/Allergic reaction 111 111
No Known Impact Or Consequence To Patient 107 107
Unspecified Musculoskeletal problem 87 87
Hemorrhage/Bleeding 82 82
Joint Swelling 71 71
Scar Tissue 63 63
Hematoma 61 61
Cyst(s) 59 59
Thrombosis/Thrombus 59 59
Fibrosis 58 58
Fatigue 54 54
Fluid Discharge 51 51
Joint Contracture 51 51
Necrosis 50 50
Erythema 49 49
Tissue Damage 49 49
Pulmonary Embolism 45 45
Muscle/Tendon Damage 42 42
Impaired Healing 39 39

Recalls
Manufacturer Recall Class Date Posted
1 DePuy Orthopaedics, Inc. II Sep-01-2021
2 DePuy Orthopaedics, Inc. II Mar-29-2021
3 DePuy Orthopaedics, Inc. II Dec-03-2016
4 DePuy Orthopaedics, Inc. II May-26-2015
5 Exactech, Inc. II Jul-24-2012
6 ZIMMER ORTHOPEDIC MFG LTD II Feb-21-2018
7 Zimmer Biomet, Inc. II Nov-07-2019
8 Zimmer Biomet, Inc. II Mar-14-2018
9 Zimmer Biomet, Inc. II Feb-22-2016
10 Zimmer Inc. II Jun-25-2009
11 Zimmer, Inc. II Oct-25-2013
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