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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, shoulder, non-constrained, metal/polymer cemented
Regulation Description Shoulder joint metal/polymer non-constrained cemented prosthesis.
Product CodeKWT
Regulation Number 888.3650
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 2
BIOMET
  2
  SUBSTANTIALLY EQUIVALENT 13
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 4
ENCORE MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 7
IMPLEX
  SUBSTANTIALLY EQUIVALENT 1
NEXA ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 1
STELKAST
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 11

Device Problems
No Information 135
Implant, removal of 116
Loose 48
Dislodged or dislocated 45
Naturally worn 35
Unknown (for use when the device problem is not known) 29
Fracture 25
Migration of device or device component 21
Loss of or failure to bond 19
Dislocated 17
Detachment of device component 16
No Known Device Problem 16
Loose or intermittent connection 15
Component(s), worn 14
Explanted 13
Fitting problem 12
Other (for use when an appropriate device code cannot be identified) 11
Break 9
Disassembly 8
Loss of osseointegration 8
No code available 8
Device remains implanted 7
Malposition of device 5
Size incorrect for patient 4
Slippage of device or device component 4
Unintended movement 4
Noise, Audible 3
Mechanical jam 3
Difficult to insert 3
Failure to Adhere or Bond 2
Disengaged 2
Tear, rip or hole in device packaging 2
Difficult to remove 2
Material deformation 2
Device operates differently than expected 2
Misassembled by Users 2
Not Applicable 2
Device-device incompatibility 1
Incompatibility problem 1
Manufacturing or shipping issue associated with device 1
Material integrity issue 1
Replace 1
Connection issue 1
Use of Device Issue 1
Improper or incorrect procedure or method 1
Device, or device fragments remain in patient 1
Misapplication 1
Material erosion 1
Component incompatible 1
Mechanical issue 1
Foreign material 1
Total Device Problems 683

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 0 1 0 4 2 2 1 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 Dec-05-2012
2 Biomet, Inc. II Sep-16-2008
3 Exactech, Inc. II Dec-22-2016
4 Exactech, Inc. II Jul-31-2012
5 Limacorporate S.p.A II Sep-02-2015
6 Zimmer Inc. II Dec-09-2010
7 Zimmer, Inc. II Feb-26-2014
8 Zimmer, Inc. II Feb-24-2014
9 Zimmer, Inc. II Dec-30-2013
10 Zimmer, Inc. II Aug-26-2013
11 Zimmer, Inc. II Nov-06-2012
12 Zimmer, Inc. II Jun-27-2012

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