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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, elbow, semi-constrained, cemented
Regulation Description Elbow joint metal/polymer semi-constrained cemented prosthesis.
Product CodeJDB
Regulation Number 888.3160
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMET
  SUBSTANTIALLY EQUIVALENT 1
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 3
  1.  K802460  HELFET ELBOW PROSTHESIS
  2.  K810847  PRITCHARD SURFACE REPLACEMENT ELBOW
  3.  K823473  POROCOAT MARK IV ELBOW
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 2
ORTHOPEDIC SYSTEMS, INC.
  1
SMALL BONE INNOVATIONS
  SUBSTANTIALLY EQUIVALENT 2
TORNIER
  SUBSTANTIALLY EQUIVALENT 6
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
No Known Device Problem 11
Explanted 10
Dislodged or dislocated 10
Implant, removal of 9
Mechanical issue 8
Detachment of device or device component 7
Fracture 6
Loose or intermittent connection 5
Break 5
Component(s), worn 5
Disassembly 4
No Information 4
Disengaged 3
Unstable 3
Improper or incorrect procedure or method 2
Unknown (for use when the device problem is not known) 2
Device operates differently than expected 2
Packaging issue 2
Dislocated 2
Loose 1
Positioning Issue 1
Incomplete or missing packaging 1
Total Device Problems 103

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

Recalls
Manufacturer Recall Class Date Posted
1 Stryker Howmedica Osteonics Corp. II Aug-20-2015
2 Tornier, Inc II Aug-29-2011

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