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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 18

Device Problems
No Information 2899
Implant, removal of 1812
Loss of or failure to bond 1311
Loose 566
Unknown (for use when the device problem is not known) 557
Naturally worn 478
Component(s), worn 344
No code available 281
Loss of osseointegration 241
Migration of device or device component 240
Other (for use when an appropriate device code cannot be identified) 202
Malposition of device 123
Break 111
Loose or intermittent connection 90
Fracture 74
Disassembly 63
Size incorrect for patient 57
Dislodged or dislocated 44
Metal shedding debris 38
Failure to Adhere or Bond 36
Noise, Audible 31
Dislocated 23
Device remains implanted 22
Unstable 20
Component(s), broken 13
Component incompatible 10
Slippage of device or device component 8
Displacement 7
Detachment of device component 6
Fitting problem 6
Tear, rip or hole in device packaging 6
Foreign material present in device 5
User used incorrect product for intended use 5
Difficult to insert 5
No Known Device Problem 4
Malfunction 3
Scratched material 3
Delivered as unsterile product 3
Unsealed device packaging 3
Incorrect measurement 2
Material separation 2
Device expiration issue 2
Couple, failure to 2
Device packaging compromised 2
Packaging issue 2
Item contaminated during manufacturing or shipping 2
Mechanical jam 2
Patient-device incompatibility 2
Connection issue 2
Delamination 2
Incomplete or missing packaging 2
Overfill 1
Device damaged prior to use 1
Component missing 1
Device operates differently than expected 1
Defective item 1
Osseointegration issue 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
Interlock(s), failure of 1
Membrane leak(s) 1
Pitted 1
Mislabeled 1
Total Device Problems 9792

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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