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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 1

Device Problems
Insufficient Information 1878
Loss of or Failure to Bond 1787
Adverse Event Without Identified Device or Use Problem 1119
Naturally Worn 299
Migration or Expulsion of Device 230
Loss of Osseointegration 183
Loose or Intermittent Connection 182
Appropriate Term/Code Not Available 172
Break 127
Migration 99
Malposition of device 89
Loosening of Implant Not Related to Bone-Ingrowth 78
Fracture 73
Device Dislodged or Dislocated 51
Unintended Movement 49
Failure To Adhere Or Bond 49
Noise, Audible 43
Inadequacy of Device Shape and/or Size 35
Unstable 32
Disassembly 22
Device-Device Incompatibility 18
Material Twisted / Bent 16
Use of Device Problem 14
Material Deformation 12
Fitting Problem 11
Mechanical Jam 11
Off-Label Use 9
No Apparent Adverse Event 9
Device Slipped 8
Physical Resistance / Sticking 8
Patient-Device Incompatibility 8
Difficult to Insert 7
Packaging Problem 7
Device Contamination with Chemical or Other Material 6
Incorrect Measurement 6
Difficult to Remove 6
Difficult to Open or Remove Packaging Material 5
Osseointegration Problem 5
Device Contaminated during manufacture or shipping 5
Delivered as Unsterile Product 5
Crack 4
Scratched Material 4
Device Packaging Compromised 4
Biocompatibility 3
Corroded 3
Device Damaged Prior to Use 3
Material Separation 3
Tear, Rip or Hole in Device Packaging 3
Defective Device 3
Device Disinfection Or Sterilization Issue 3
Device Issue 3
Component Incompatible 2
Ambient Noise Problem 2
Metal Shedding Debris 2
Incomplete or Missing Packaging 2
Component Missing 2
Entrapment of Device 2
Unsealed Device Packaging 2
Difficult to Open or Close 1
Device Difficult to Maintain 1
Connection Problem 1
Shipping Damage or Problem 1
Defective Component 1
Structural Problem 1
Material Fragmentation 1
Delamination 1
Separation Problem 1
Missing Information 1
Device Operates Differently Than Expected 1
Misconnection 1
Positioning Problem 1
Material Too Rigid or Stiff 1
Material Erosion 1
Complete Blockage 1
Overfill 1
Difficult to Advance 1
Failure to Osseointegrate 1
Pitted 1
Total Device Problems 6843

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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