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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous
Regulation Description Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
Product CodeMBL
Regulation Number 888.3358
Device Class 2


Premarket Reviews
ManufacturerDecision
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 7
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Dislodged or dislocated 19
No Information 11
No Known Device Problem 7
Loose or intermittent connection 6
No code available 4
Unintended movement 3
Migration of device or device component 3
Fracture 2
Difficult to insert 2
Slippage of device or device component 2
Connection issue 2
Detachment of device or device component 1
Device operates differently than expected 1
Device-device incompatibility 1
Metal shedding debris 1
Malposition of device 1
Naturally worn 1
Leak 1
Failure to Adhere or Bond 1
Detachment of device component 1
Corrosion 1
Misconnection 1
User used incorrect product for intended use 1
Material separation 1
Osseointegration issue 1
Positioning Issue 1
Total Device Problems 76

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 1 0 0
Class II 0 0 0 0 1 0 1 1 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 MicroPort Orthopedics, Inc. I Sep-28-2015
2 Ortho Development Corporation II Jun-20-2011
3 Smith & Nephew Inc II Feb-21-2014
4 Smith & Nephew Inc II Aug-08-2013

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