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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
No Information 156
Explanted 79
Fracture 65
Migration of device or device component 65
Component(s), worn 43
Implant, removal of 41
Loose 40
Break 39
No code available 28
Dislodged or dislocated 23
Naturally worn 21
Loose or intermittent connection 19
Failure to Adhere or Bond 17
Disassembly 16
Disengaged 14
Detachment of device component 11
Device inoperable 9
No Known Device Problem 9
Device packaging compromised 9
Unstable 8
Unknown (for use when the device problem is not known) 7
Difficult to position 7
Device remains implanted 7
Difficult to insert 7
Fitting problem 6
Size incorrect for patient 6
Component missing 5
Dislocated 5
Component incompatible 4
Slippage of device or device component 4
Material deformation 4
Device operates differently than expected 2
Malposition of device 2
Noise, Audible 2
Other (for use when an appropriate device code cannot be identified) 2
Foreign material 2
Material erosion 2
Loss of or failure to bond 1
Mechanical issue 1
Metal shedding debris 1
Difficult to remove 1
Replace 1
Material rigid or stiff 1
Material puncture 1
Unintended system motion 1
Particulates 1
Biocompatibility issue 1
Detachment of device or device component 1
Loss of osseointegration 1
Material integrity issue 1
Total Device Problems 799

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 1 1 0 1 2 0 1 0 1 0
Class III 0 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 Biomet, Inc. II Sep-08-2016
6 Zimmer Inc. II Apr-02-2009
7 Zimmer, Inc. II Dec-18-2012

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