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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 2017
5 6 0 3 6 5 8 2 4 6 2

Device Problems
No Information 405
Migration of device or device component 124
Dislodged or dislocated 59
Fracture 27
Unstable 22
Implant, removal of 22
No Known Device Problem 18
Mechanical issue 12
Detachment of device component 11
Loose or intermittent connection 8
Material erosion 8
Slippage of device or device component 8
Dislocated 7
No code available 7
Malposition of device 6
Loose 6
Explanted 5
Break 4
Detachment of device or device component 4
Device operates differently than expected 4
Positioning Issue 4
Noise, Audible 4
Unintended movement 3
Size incorrect for patient 3
Device markings issue 3
Material fragmentation 3
Failure to Adhere or Bond 3
User used incorrect product for intended use 3
Metal shedding debris 3
Use of Device Issue 2
Collapse 2
Entrapment of device or device component 2
Component falling 2
Structural problem 2
Packaging issue 2
Scratched material 2
Material deformation 2
Naturally worn 2
Overcorrection 1
Device, removal of (non-implant) 1
Device packaging compromised 1
Foreign material present in device 1
Manufacturing or shipping issue associated with device 1
Device handling issue 1
Component incompatible 1
Disassembly 1
Inadequate instructions for healthcare professional 1
Tear, rip or hole in device packaging 1
Failure to osseointegrate 1
Fitting problem 1
Component missing 1
Device remains implanted 1
Difficult to remove 1
Material rupture 1
Material separation 1
Sticking 1
Unsealed device packaging 1
Total Device Problems 833

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

Recalls
Manufacturer Recall Class Date Posted
1 Biomet U.K., Ltd. II Feb-22-2017
2 Biomet U.K., Ltd. II Apr-15-2013
3 Biomet, Inc. II Feb-03-2009
4 Endotec, Inc. II Jan-11-2012

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