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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)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
4 6 12 4 8 11 15 21 23 17 2

Device Problems
No Information 2562
Implant, removal of 1812
Loss of or failure to bond 1122
Loose 566
Unknown (for use when the device problem is not known) 557
Naturally worn 438
Component(s), worn 344
No code available 265
Other (for use when an appropriate device code cannot be identified) 202
Migration of device or device component 192
Loss of osseointegration 191
Malposition of device 110
Loose or intermittent connection 88
Break 86
Disassembly 60
Fracture 54
Size incorrect for patient 53
Dislodged or dislocated 41
Metal shedding debris 37
Failure to Adhere or Bond 32
Noise, Audible 26
Dislocated 23
Device remains implanted 22
Unstable 16
Component(s), broken 13
Component incompatible 10
Slippage of device or device component 8
Displacement 7
Detachment of device component 6
Difficult to insert 5
Foreign material present in device 5
Fitting problem 5
Tear, rip or hole in device packaging 5
No Known Device Problem 4
Malfunction 3
Delivered as unsterile product 3
Unsealed device packaging 3
User used incorrect product for intended use 3
Device expiration issue 2
Couple, failure to 2
Patient-device incompatibility 2
Packaging issue 2
Scratched material 2
Delamination 2
Device operates differently than expected 1
Device packaging compromised 1
Connection issue 1
Item contaminated during manufacturing or shipping 1
Mechanical jam 1
Device damaged prior to use 1
Component missing 1
Incomplete or missing packaging 1
Crack 1
Design/structure problem 1
Material erosion 1
Component(s), overheating of 1
Corrosion 1
Device clogged 1
Collapse 1
Collimator design problem 1
Mislabeled 1
Incorrect measurement 1
Membrane leak(s) 1
Material separation 1
Interlock(s), failure of 1
Total Device Problems 9012

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 1 1 1 0 0 1 1 0 1 2 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 DePuy Orthopaedics, Inc. II Dec-03-2016
2 DePuy Orthopaedics, Inc. II May-26-2015
3 Depuy Orthopaedics, Inc. II Sep-17-2008
4 Depuy Orthopaedics, Inc. II Dec-06-2007
5 Exactech, Inc. II Jul-24-2012
6 Zimmer Biomet, Inc. II Feb-22-2016
7 Zimmer Inc. II Jun-25-2009
8 Zimmer, Inc. II Oct-25-2013

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