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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 47
Component(s), worn 43
Implant, removal of 41
Loose 40
No Information 37
Break 35
Dislodged or dislocated 22
Loose or intermittent connection 19
No code available 19
Disassembly 14
Disengaged 14
Failure to Adhere or Bond 13
Device inoperable 9
Naturally worn 9
Device packaging compromised 9
Device remains implanted 7
Unknown (for use when the device problem is not known) 7
Fitting problem 6
No Known Device Problem 6
Dislocated 5
Migration of device or device component 5
Difficult to insert 4
Detachment of device component 4
Slippage of device or device component 4
Component missing 4
Component incompatible 3
Foreign material 2
Other (for use when an appropriate device code cannot be identified) 2
Metal shedding debris 1
Replace 1
Material rigid or stiff 1
Material integrity issue 1
Loss of osseointegration 1
Biocompatibility issue 1
Detachment of device or device component 1
Unintended system motion 1
Particulates 1
Material puncture 1
Loss of or failure to bond 1
Total Device Problems 520

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

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