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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
Implant, removal of 116
No Information 116
Loose 48
Dislodged or dislocated 36
Naturally worn 35
Unknown (for use when the device problem is not known) 29
Fracture 19
Loss of or failure to bond 18
Dislocated 17
Loose or intermittent connection 15
Component(s), worn 14
Explanted 13
Migration of device or device component 13
Fitting problem 12
No Known Device Problem 12
Other (for use when an appropriate device code cannot be identified) 11
Break 9
Disassembly 8
Loss of osseointegration 8
Device remains implanted 7
Detachment of device component 7
No code available 7
Malposition of device 5
Size incorrect for patient 4
Slippage of device or device component 4
Difficult to insert 3
Unintended movement 3
Not Applicable 2
Tear, rip or hole in device packaging 2
Noise, Audible 2
Material deformation 2
Failure to Adhere or Bond 2
Disengaged 2
Material erosion 1
Component incompatible 1
Mechanical issue 1
Foreign material 1
Use of Device Issue 1
Improper or incorrect procedure or method 1
Device, or device fragments remain in patient 1
Difficult to remove 1
Replace 1
Connection issue 1
Device operates differently than expected 1
Device-device incompatibility 1
Misapplication 1
Material integrity issue 1
Mechanical jam 1
Manufacturing or shipping issue associated with device 1
Total Device Problems 617

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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