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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
4 6 12 4 8 11 15 21 23 8

Device Problems
No Information 2113
Implant, removal of 1812
Loss of or failure to bond 916
Loose 566
Unknown (for use when the device problem is not known) 557
Naturally worn 398
Component(s), worn 344
No code available 247
Other (for use when an appropriate device code cannot be identified) 202
Loss of osseointegration 162
Migration of device or device component 145
Malposition of device 101
Loose or intermittent connection 87
Disassembly 56
Break 49
Size incorrect for patient 49
Fracture 43
Dislodged or dislocated 38
Metal shedding debris 36
Failure to Adhere or Bond 25
Dislocated 23
Device remains implanted 22
Unstable 14
Component(s), broken 13
Noise, Audible 13
Component incompatible 9
Slippage of device or device component 8
Displacement 7
Detachment of device component 6
Difficult to insert 5
Foreign material present in device 5
Tear, rip or hole in device packaging 5
Fitting problem 4
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
Packaging issue 2
Patient-device incompatibility 2
Delamination 2
Device operates differently than expected 1
Connection issue 1
Scratched material 1
Device damaged prior to use 1
Component missing 1
Item contaminated during manufacturing or shipping 1
Design/structure problem 1
Device clogged 1
Collapse 1
Collimator design problem 1
Component(s), overheating of 1
Material erosion 1
Mislabeled 1
Incorrect measurement 1
Membrane leak(s) 1
Material separation 1
Interlock(s), failure of 1
Total Device Problems 8123

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

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

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