• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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 49
Component(s), worn 43
Implant, removal of 41
No Information 41
Loose 40
Break 39
Dislodged or dislocated 22
No code available 21
Loose or intermittent connection 19
Disassembly 15
Disengaged 14
Failure to Adhere or Bond 13
Device inoperable 9
Device packaging compromised 9
Naturally worn 9
Migration of device or device component 8
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
Detachment of device component 4
Difficult to insert 4
Component missing 4
Slippage of device or device component 4
Component incompatible 3
Foreign material 2
Other (for use when an appropriate device code cannot be identified) 2
Loss of osseointegration 1
Biocompatibility issue 1
Detachment of device or device component 1
Metal shedding debris 1
Replace 1
Material rigid or stiff 1
Mechanical issue 1
Unintended system motion 1
Particulates 1
Material puncture 1
Loss of or failure to bond 1
Material integrity issue 1
Total Device Problems 537

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

-
-