• 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)
2020 2021 2022 2023 2024 2025
28 18 30 17 23 0

MDR Year MDR Reports MDR Events
2020 1864 1864
2021 2644 2644
2022 2324 2324
2023 1593 1593
2024 1234 1234
2025 93 93

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 7040 7040
Loss of or Failure to Bond 1357 1357
Naturally Worn 432 432
Migration 251 251
Unintended Movement 169 169
Osseointegration Problem 169 169
Device Dislodged or Dislocated 126 126
Device Contaminated During Manufacture or Shipping 102 102
Fracture 86 86
Difficult to Open or Remove Packaging Material 69 69
Use of Device Problem 61 61
Off-Label Use 53 53
Noise, Audible 51 51
Appropriate Term/Code Not Available 42 42
Tear, Rip or Hole in Device Packaging 41 41
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 23 23
Break 20 20
Device-Device Incompatibility 20 20
Insufficient Information 17 17
Patient Device Interaction Problem 17 17
Malposition of Device 16 16
Material Twisted/Bent 14 14
Device Damaged Prior to Use 12 12
Improper or Incorrect Procedure or Method 12 12
Inadequacy of Device Shape and/or Size 12 12
Difficult to Advance 11 11
Expiration Date Error 10 10
Patient-Device Incompatibility 10 10
Incorrect Measurement 9 9
Mechanical Jam 8 8
Contamination /Decontamination Problem 6 6
Inaccurate Information 6 6
Unstable 5 5
Migration or Expulsion of Device 4 4
Illegible Information 4 4
Physical Resistance/Sticking 3 3
Incomplete or Missing Packaging 3 3
Missing Information 3 3
Corroded 3 3
Defective Device 2 2
Computer Software Problem 2 2
Scratched Material 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Device Markings/Labelling Problem 2 2
Difficult to Remove 1 1
Packaging Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 3410 3410
Unspecified Infection 2095 2095
Joint Laxity 1781 1781
No Code Available 1597 1597
Insufficient Information 981 981
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 695 695
Adhesion(s) 652 652
Swelling/ Edema 523 523
Muscular Rigidity 488 488
Loss of Range of Motion 487 487
Fall 325 325
Synovitis 257 257
No Clinical Signs, Symptoms or Conditions 223 223
Unspecified Tissue Injury 202 202
Osteolysis 197 197
Discomfort 196 196
Inadequate Osseointegration 193 193
Ambulation Difficulties 185 185
Edema 175 175
Inflammation 147 147
Limited Mobility Of The Implanted Joint 136 136
Bone Fracture(s) 129 129
Wound Dehiscence 123 123
Joint Dislocation 105 105
Unspecified Musculoskeletal problem 87 87
Hemorrhage/Bleeding 83 83
Foreign Body Reaction 74 74
No Consequences Or Impact To Patient 68 68
Hypersensitivity/Allergic reaction 66 66
Thrombosis/Thrombus 59 59
Joint Contracture 53 53
Fluid Discharge 52 52
Fatigue 49 49
Erythema 48 48
Cyst(s) 45 45
Injury 45 45
Muscle/Tendon Damage 43 43
Hematoma 42 42
Scar Tissue 41 41
Impaired Healing 41 41
Pulmonary Embolism 40 40
Necrosis 36 36
Sepsis 33 33
Fever 29 29
Abscess 27 27
Fibrosis 25 25
Ossification 23 23
Nerve Damage 19 19
Joint Disorder 18 18
Local Reaction 17 17

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