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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)
2015 2016 2017 2018 2019 2020
23 17 21 27 30 15

Device Problems
Loss of or Failure to Bond 2101
Adverse Event Without Identified Device or Use Problem 1886
Insufficient Information 1880
Naturally Worn 330
Migration or Expulsion of Device 234
Loss of Osseointegration 202
Loose or Intermittent Connection 182
Appropriate Term/Code Not Available 181
Migration 158
Break 132
Malposition of Device 100
Loosening of Implant Not Related to Bone-Ingrowth 96
Unintended Movement 86
Fracture 82
Device Dislodged or Dislocated 68
Failure To Adhere Or Bond 48
Noise, Audible 46
Inadequacy of Device Shape and/or Size 43
Material Deformation 38
Unstable 32
Material Twisted/Bent 29
Device-Device Incompatibility 28
Use of Device Problem 27
Disassembly 22
Mechanical Jam 17
Fitting Problem 12
Off-Label Use 12
Difficult to Insert 12
Physical Resistance/Sticking 11
Osseointegration Problem 9
No Apparent Adverse Event 9
Device Contaminated During Manufacture or Shipping 9
Incorrect Measurement 8
Device Slipped 8
Patient-Device Incompatibility 8
Packaging Problem 7
Device Contamination with Chemical or Other Material 6
Patient Device Interaction Problem 6
Difficult to Remove 6
Difficult to Open or Remove Packaging Material 5
Product Quality Problem 5
Delivered as Unsterile Product 5
Crack 4
Tear, Rip or Hole in Device Packaging 4
Device Damaged Prior to Use 4
Scratched Material 4
Device Packaging Compromised 4
Biocompatibility 3
Corroded 3
Material Separation 3
Defective Device 3
Device Disinfection Or Sterilization Issue 3
Device Issue 3
Difficult to Advance 2
Component Incompatible 2
Metal Shedding Debris 2
Ambient Noise Problem 2
Contamination /Decontamination Problem 2
Incomplete or Missing Packaging 2
Entrapment of Device 2
Unsealed Device Packaging 2
Component Missing 2
Missing Information 2
Separation Problem 1
Structural Problem 1
Delamination 1
Defective Component 1
Material Fragmentation 1
Device Markings/Labelling Problem 1
Device Difficult to Maintain 1
Difficult to Open or Close 1
Improper or Incorrect Procedure or Method 1
Shipping Damage or Problem 1
Expiration Date Error 1
Connection Problem 1
Misconnection 1
Device Operates Differently Than Expected 1
Positioning Problem 1
Material Too Rigid or Stiff 1
Complete Blockage 1
Inaccurate Information 1
Pitted 1
Failure to Osseointegrate 1
Overfill 1
Illegible Information 1
Material Integrity Problem 1
Total Device Problems 8267

Recalls
Manufacturer Recall Class Date Posted
1 DePuy Orthopaedics, Inc. II Dec-03-2016
2 DePuy Orthopaedics, Inc. II May-26-2015
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
6 Zimmer Biomet, Inc. II Feb-22-2016

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