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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
Definition This type of device is designed to allow for motion between the plastic tibial bearing and metal tibial baseplate components of a unicompartmental knee prosthesis. It is intended to replace part of a knee joint in order to relieve pain and restore knee function, for indications such as osteoarthritis and avascular necrosis.
Product CodeNRA
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
5 6 0 3 6 5 8 2 4 0

Device Problems
No Information 139
Migration of device or device component 51
Dislodged or dislocated 35
Implant, removal of 22
Unstable 16
Mechanical issue 10
Detachment of device component 9
Fracture 9
No Known Device Problem 9
Loose or intermittent connection 8
Slippage of device or device component 8
Dislocated 7
Loose 6
Material erosion 5
Explanted 5
Malposition of device 5
No code available 4
Noise, Audible 4
Positioning Issue 4
Break 4
Device operates differently than expected 4
Failure to Adhere or Bond 3
Size incorrect for patient 2
Collapse 2
Unintended movement 2
Material deformation 2
Device markings issue 2
Structural problem 2
Device, removal of (non-implant) 1
Metal shedding debris 1
Foreign material present in device 1
Manufacturing or shipping issue associated with device 1
Naturally worn 1
Overcorrection 1
Packaging issue 1
Component incompatible 1
Device remains implanted 1
Difficult to remove 1
Material rupture 1
Material separation 1
Total Device Problems 391

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 0 0 1 0 0 1 1 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Biomet U.K., Ltd. II Apr-15-2013
2 Biomet, Inc. II Feb-03-2009
3 Endotec, Inc. II Jan-11-2012

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