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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, elbow, constrained, cemented
Regulation Description Elbow joint metal/polymer constrained cemented prosthesis.
Product CodeJDC
Regulation Number 888.3150
Device Class 2


Premarket Reviews
ManufacturerDecision
ARROW INTL., INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET
  SUBSTANTIALLY EQUIVALENT 10
DEPUY INTL., LTD.
  1
  SUBSTANTIALLY EQUIVALENT 3
TORNIER
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  1
  SUBSTANTIALLY EQUIVALENT 6

Device Problems
Explanted 79
Fracture 46
Component(s), worn 43
Implant, removal of 41
Loose 40
Break 35
No Information 26
Dislodged or dislocated 22
Loose or intermittent connection 19
No code available 17
Disassembly 14
Disengaged 14
Failure to Adhere or Bond 10
Device inoperable 9
Device packaging compromised 9
Naturally worn 9
Device remains implanted 7
Unknown (for use when the device problem is not known) 7
Fitting problem 6
Dislocated 5
Slippage of device or device component 4
Component incompatible 3
Migration of device or device component 3
Component missing 3
Foreign material 2
Detachment of device component 2
Other (for use when an appropriate device code cannot be identified) 2
Difficult to insert 2
Detachment of device or device component 1
Loss of osseointegration 1
Material rigid or stiff 1
Material integrity issue 1
Loss of or failure to bond 1
Material puncture 1
Unintended system motion 1
Replace 1
Total Device Problems 487

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 1 1 0 1 2 0 1 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Jun-26-2014
2 Biomet, Inc. II Feb-21-2012
3 Biomet, Inc. II Jun-24-2011
4 Biomet, Inc. II Oct-03-2008
5 Zimmer Inc. II Apr-02-2009
6 Zimmer, Inc. II Dec-18-2012

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