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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 50
No Information 44
Component(s), worn 43
Implant, removal of 41
Break 40
Loose 40
Dislodged or dislocated 23
No code available 21
Loose or intermittent connection 19
Disassembly 15
Disengaged 14
Failure to Adhere or Bond 13
Naturally worn 12
Migration of device or device component 10
Device inoperable 9
Device packaging compromised 9
Device remains implanted 7
Unknown (for use when the device problem is not known) 7
No Known Device Problem 6
Fitting problem 6
Dislocated 5
Component missing 4
Detachment of device component 4
Component incompatible 4
Slippage of device or device component 4
Difficult to insert 4
Other (for use when an appropriate device code cannot be identified) 2
Foreign material 2
Material integrity issue 1
Material puncture 1
Particulates 1
Metal shedding debris 1
Loss of or failure to bond 1
Replace 1
Unintended system motion 1
Detachment of device or device component 1
Mechanical issue 1
Biocompatibility issue 1
Material rigid or stiff 1
Loss of osseointegration 1
Total Device Problems 549

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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