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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, ankle, uncemented, non-constrained
Definition An ankle joint metal/polymer non-constrained uncemented prosthesis is a device intended to be implanted to replace an ankle joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a tibial component made of alloys, such as cobalt-chromium-molybdenum, and a talar component made of ultra-high molecular weight polyethylene.
Product CodeNTG
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
0 0 1 2 0 0 2 2 0 0

Device Problems
No Known Device Problem 59
No Information 48
Fracture 36
Break 27
No code available 22
Size incorrect for patient 13
Unintended movement 12
Device operates differently than expected 11
Improper or incorrect procedure or method 10
Malposition of device 8
Unstable 8
Naturally worn 8
Patient-device incompatibility 7
Migration of device or device component 5
Degraded 4
Failure to osseointegrate 4
Entrapment of device or device component 3
Slippage of device or device component 3
Use of Device Issue 2
Material erosion 2
Dislodged or dislocated 2
Material deformation 2
Therapeutic or diagnostic output failure 2
Material integrity issue 1
Human-Device Interface Issue 1
Positioning Issue 1
Device expiration issue 1
Flaked 1
Device Cleaning Issue 1
Detachment of device component 1
Loose or intermittent connection 1
Stretched 1
Bent 1
Total Device Problems 308

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