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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
  SUBSTANTIALLY EQUIVALENT 12
  SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS 2
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 4
ENCORE MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 6
IMPLEX
  SUBSTANTIALLY EQUIVALENT 1
NEXA ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 1
STELKAST
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 9

Device Problems
Implant, removal of 116
No Information 66
Loose 47
Unknown (for use when the device problem is not known) 29
Dislodged or dislocated 24
Naturally worn 18
Dislocated 17
Component(s), worn 14
Explanted 12
Fitting problem 11
Other (for use when an appropriate device code cannot be identified) 11
Loss of or failure to bond 9
Loose or intermittent connection 9
Loss of osseointegration 8
Device remains implanted 7
Detachment of device component 6
Disassembly 6
Fracture 6
No code available 5
Size incorrect for patient 4
Break 4
Difficult to insert 2
Disengaged 2
Tear, rip or hole in device packaging 2
Malposition of device 2
Device, or device fragments remain in patient 1
Mechanical issue 1
Migration of device or device component 1
Misapplication 1
Component incompatible 1
Total Device Problems 442

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 1 0 1 0 4 0
Class III 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 Zimmer Inc. II Dec-09-2010
5 Zimmer, Inc. II Nov-06-2012
6 Zimmer, Inc. II Jun-27-2012

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