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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, shoulder, semi-constrained, metal/polymer cemented
Regulation Description Shoulder joint metal/polymer semi-constrained cemented prosthesis.
Product CodeKWS
Regulation Number 888.3660
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 5
ARTHROCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
ASCENSION ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET
  SUBSTANTIALLY EQUIVALENT 9
BIOPRO, INC.
  SUBSTANTIALLY EQUIVALENT 1
CENTERPULSE ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CLEVELAND CLINIC
  SUBSTANTIALLY EQUIVALENT 1
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 18
  SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS 1
ENCORE MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 12
  SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS 1
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 10
FOURNITURES HOSPITALIERES INDUSTRIE
  SUBSTANTIALLY EQUIVALENT 2
IMPLEX
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 7
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 4
SULZER
  SUBSTANTIALLY EQUIVALENT 5
TORNIER
  SUBSTANTIALLY EQUIVALENT 30
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 7

Device Problems
Implant, removal of 339
No Information 129
Loose 127
Dislodged or dislocated 102
Dislocated 84
Naturally worn 61
Unknown (for use when the device problem is not known) 51
Fracture 51
Other (for use when an appropriate device code cannot be identified) 43
Component(s), worn 41
Loss of or failure to bond 41
Device remains implanted 33
Malfunction 29
Loss of osseointegration 27
Disassembly 24
Loose or intermittent connection 20
Explanted 15
Break 15
No code available 12
Malposition of device 11
Migration of device or device component 11
Component(s), broken 9
Size incorrect for patient 9
Fitting problem 7
Interlock(s), failure of 6
Disengaged 6
Metal shedding debris 5
Difficult to insert 3
Defective component 2
Tear, rip or hole in device packaging 2
Connection issue 2
No Known Device Problem 1
Packaging issue 1
Slippage of device or device component 1
Tip breakage 1
Device, or device fragments remain in patient 1
Bent 1
Delivered as unsterile product 1
Incorrect measurement 1
Detachment of device component 1
Total Device Problems 1326

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 5 1 4 3 2 2 1
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Jan-09-2013
2 Biomet, Inc. II Jun-09-2011
3 Biomet, Inc. II Dec-16-2010
4 Depuy Orthopaedics, Inc. II Jan-15-2009
5 Depuy Orthopaedics, Inc. II Nov-17-2007
6 Encore Medical, Lp II Jul-06-2011
7 Encore Medical, Lp II Dec-22-2010
8 Encore Medical, Lp II Dec-19-2007
9 Encore Medical, Lp II Sep-25-2007
10 Exactech, Inc. II Jul-31-2012
11 Smith & Nephew Inc II Apr-07-2010
12 Smith & Nephew Inc II Feb-03-2009
13 Stryker Howmedica Osteonics Corp. II Jan-26-2009
14 Stryker Howmedica Osteonics Corp. II Jun-26-2008
15 Stryker Howmedica Osteonics Corp. II Nov-01-2007
16 Tournier, Inc. II Jan-23-2009
17 Zimmer Inc. II Aug-23-2007
18 Zimmer, Inc. II Nov-06-2012

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