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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 75
Loose 48
Dislodged or dislocated 30
Unknown (for use when the device problem is not known) 29
Naturally worn 26
Dislocated 17
Loss of or failure to bond 16
Loose or intermittent connection 15
Component(s), worn 14
Explanted 13
Fracture 13
Fitting problem 11
Other (for use when an appropriate device code cannot be identified) 11
No Known Device Problem 11
Loss of osseointegration 8
Disassembly 8
Break 7
Detachment of device component 7
Device remains implanted 7
No code available 7
Size incorrect for patient 4
Slippage of device or device component 4
Malposition of device 2
Tear, rip or hole in device packaging 2
Difficult to insert 2
Disengaged 2
Noise, Audible 2
Unintended movement 1
Failure to Adhere or Bond 1
Mechanical issue 1
Migration of device or device component 1
Misapplication 1
Component incompatible 1
Material integrity issue 1
Mechanical jam 1
Connection issue 1
Device operates differently than expected 1
Use of Device Issue 1
Device, or device fragments remain in patient 1
Difficult to remove 1
Replace 1
Total Device Problems 521

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 0 1 0 4 2 2 1 0
Class III 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 Jul-31-2012
4 Limacorporate S.p.A II Sep-02-2015
5 Zimmer Inc. II Dec-09-2010
6 Zimmer, Inc. II Feb-26-2014
7 Zimmer, Inc. II Feb-24-2014
8 Zimmer, Inc. II Dec-30-2013
9 Zimmer, Inc. II Aug-26-2013
10 Zimmer, Inc. II Nov-06-2012
11 Zimmer, Inc. II Jun-27-2012

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