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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)
2014 2015 2016 2017 2018 2019
21 23 17 21 27 22

Device Problems
Insufficient Information 1957
Loss of or Failure to Bond 1467
Adverse Event Without Identified Device or Use Problem 700
Naturally Worn 281
Migration or Expulsion of Device 227
Loose or Intermittent Connection 180
Loss of Osseointegration 178
Appropriate Term/Code Not Available 177
Break 126
Migration 79
Malposition of device 76
Fracture 69
Failure To Adhere Or Bond 58
Loosening of Implant Not Related to Bone-Ingrowth 56
Device Dislodged or Dislocated 42
Noise, Audible 37
Unstable 33
Inadequacy of Device Shape and/or Size 32
Unintended Movement 29
Disassembly 22
Device-Device Incompatibility 14
Material Deformation 12
Material Twisted / Bent 12
Fitting Problem 12
Off-Label Use 10
Mechanical Jam 10
No Apparent Adverse Event 8
Device Slipped 8
Difficult to Remove 6
Incorrect Measurement 6
Physical Resistance / Sticking 6
Packaging Problem 6
Device Contamination with Chemical or Other Material 6
Patient-Device Incompatibility 6
Difficult to Insert 6
Osseointegration Problem 5
Scratched Material 5
Delivered as Unsterile Product 5
Use of Device Problem 5
Difficult to Open or Remove Packaging Material 4
Device Contaminated during manufacture or shipping 4
Device Packaging Compromised 4
Device Disinfection Or Sterilization Issue 3
Defective Device 3
Biocompatibility 3
Metal Shedding Debris 3
Device Damaged Prior to Use 3
Device Issue 3
Tear, Rip or Hole in Device Packaging 3
Unsealed Device Packaging 3
Crack 3
Entrapment of Device 2
Component Incompatible 2
Corroded 2
Component Missing 2
Incomplete or Missing Packaging 2
Material Separation 2
Ambient Noise Problem 2
Delamination 2
Device Operates Differently Than Expected 1
Difficult to Advance 1
Difficult to Open or Close 1
Connection Problem 1
Structural Problem 1
Positioning Problem 1
Device Difficult to Maintain 1
Separation Problem 1
Shipping Damage or Problem 1
Material Too Rigid or Stiff 1
Failure to Osseointegrate 1
Overfill 1
Defective Component 1
Complete Blockage 1
Material Erosion 1
Pitted 1
Misconnection 1
Material Fragmentation 1
Total Device Problems 6047

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 Mar-14-2018
5 Zimmer Biomet, Inc. II Feb-22-2016

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