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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 6

Device Problems
No Information 342
Migration of device or device component 111
Dislodged or dislocated 55
Implant, removal of 22
Unstable 19
Fracture 16
No Known Device Problem 14
Mechanical issue 12
Detachment of device component 10
Loose or intermittent connection 8
Slippage of device or device component 8
Dislocated 7
Material erosion 7
Loose 6
Malposition of device 6
Explanted 5
Break 4
Device operates differently than expected 4
Positioning Issue 4
No code available 4
Noise, Audible 4
Unintended movement 3
Naturally worn 3
Size incorrect for patient 3
Detachment of device or device component 3
Failure to Adhere or Bond 3
Metal shedding debris 3
Material fragmentation 3
User used incorrect product for intended use 2
Collapse 2
Component falling 2
Use of Device Issue 2
Device markings issue 2
Structural problem 2
Material deformation 2
Scratched material 2
Overcorrection 1
Packaging issue 1
Foreign material present in device 1
Manufacturing or shipping issue associated with device 1
Device, removal of (non-implant) 1
Tear, rip or hole in device packaging 1
Failure to osseointegrate 1
Component missing 1
Sticking 1
Component incompatible 1
Entrapment of device or device component 1
Device remains implanted 1
Difficult to remove 1
Material rupture 1
Material separation 1
Total Device Problems 720

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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