Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 5

MDR Year MDR Reports MDR Events
2018 1265 1265
2019 1968 1968
2020 1864 1864
2021 2650 2650
2022 2353 2353
2023 374 374

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 6311 6311
Loss of or Failure to Bond 2143 2143
Naturally Worn 453 453
Insufficient Information 331 331
Migration 313 313
Unintended Movement 191 191
Loose or Intermittent Connection 171 171
Appropriate Term/Code Not Available 150 150
Device Dislodged or Dislocated 132 132
Osseointegration Problem 120 120
Loosening of Implant Not Related to Bone-Ingrowth 102 102
Fracture 93 93
Device Contaminated During Manufacture or Shipping 87 87
Loss of Osseointegration 78 78
Difficult to Open or Remove Packaging Material 68 68
Use of Device Problem 68 68
Malposition of Device 65 65
Break 56 56
Off-Label Use 55 55
Noise, Audible 55 55
Migration or Expulsion of Device 48 48
Material Deformation 41 41
Tear, Rip or Hole in Device Packaging 40 40
Difficult to Insert 39 39
Device-Device Incompatibility 34 34
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
No Apparent Adverse Event 17 17
Difficult to Advance 13 13
Patient-Device Incompatibility 12 12
Incorrect Measurement 11 11
Device Damaged Prior to Use 11 11
Physical Resistance/Sticking 11 11
Fitting Problem 9 9
Packaging Problem 9 9
Improper or Incorrect Procedure or Method 7 7
Product Quality Problem 6 6
Difficult to Remove 6 6
Contamination /Decontamination Problem 6 6
Inaccurate Information 6 6
Expiration Date Error 5 5
Delivered as Unsterile Product 5 5
Defective Device 4 4
Missing Information 4 4
Illegible Information 4 4
Biocompatibility 3 3
Device Issue 3 3
Device Disinfection Or Sterilization Issue 3 3
Scratched Material 3 3
Crack 3 3
Disassembly 3 3
Entrapment of Device 3 3
Computer Software Problem 2 2
Corroded 2 2
Material Integrity Problem 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Device Packaging Compromised 2 2
Device Contamination with Chemical or Other Material 2 2
Device Markings/Labelling Problem 2 2
Device Operates Differently Than Expected 1 1
Device Damaged by Another Device 1 1
Detachment of Device or Device Component 1 1
Difficult to Open or Close 1 1
Structural Problem 1 1
Positioning Problem 1 1
Material Erosion 1 1
Nonstandard Device 1 1
Material Fragmentation 1 1
Unsealed Device 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
Defective Component 1 1
Component Missing 1 1
Incomplete or Missing Packaging 1 1
Separation Problem 1 1
Device Difficult to Maintain 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 4249 4249
No Code Available 3698 3698
Unspecified Infection 1892 1892
Joint Laxity 1319 1319
Adhesion(s) 716 716
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 707 707
Insufficient Information 632 632
Not Applicable 518 518
Loss of Range of Motion 481 481
Swelling/ Edema 440 440
Muscular Rigidity 431 431
Edema 338 338
No Consequences Or Impact To Patient 283 283
Synovitis 267 267
Osteolysis 262 262
Fall 260 260
Limited Mobility Of The Implanted Joint 237 237
Discomfort 231 231
Inadequate Osseointegration 194 194
Ambulation Difficulties 189 189
No Clinical Signs, Symptoms or Conditions 167 167
Inflammation 157 157
Bone Fracture(s) 133 133
Unspecified Tissue Injury 127 127
Swelling 126 126
Injury 121 121
Joint Disorder 119 119
Wound Dehiscence 117 117
Joint Dislocation 92 92
Hypersensitivity/Allergic reaction 84 84
Hemorrhage/Bleeding 69 69
Foreign Body Reaction 65 65
Hematoma 58 58
Scar Tissue 58 58
Fibrosis 53 53
Cyst(s) 50 50
Erythema 49 49
Thrombosis/Thrombus 49 49
Fatigue 48 48
Necrosis 48 48
No Known Impact Or Consequence To Patient 46 46
Joint Contracture 45 45
Fluid Discharge 45 45
Unspecified Musculoskeletal problem 44 44
Muscle/Tendon Damage 37 37
Tissue Damage 37 37
Pulmonary Embolism 35 35
Impaired Healing 35 35
Fever 34 34
Abscess 28 28
Sepsis 27 27
Weakness 27 27
Scarring 26 26
Anemia 23 23
Thrombosis 22 22
Local Reaction 21 21
Rash 16 16
Failure of Implant 16 16
Post Operative Wound Infection 16 16
Nerve Damage 15 15
Low Blood Pressure/ Hypotension 14 14
Ossification 14 14
Cellulitis 14 14
No Information 14 14
Deformity/ Disfigurement 13 13
Pocket Erosion 10 10
Itching Sensation 9 9
Heart Failure 8 8
Hypoesthesia 7 7
Numbness 7 7
Thromboembolism 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
Physical Asymmetry 5 5
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
Confusion/ Disorientation 3 3
Blood Loss 3 3
Chills 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
-
-