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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 9
ARTHROCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
ASCENSION ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
BIOMET
  SUBSTANTIALLY EQUIVALENT 12
BIOPRO, INC.
  SUBSTANTIALLY EQUIVALENT 1
CENTERPULSE ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CLEVELAND CLINIC
  SUBSTANTIALLY EQUIVALENT 1
DEPUY INTL., LTD.
  1
  SUBSTANTIALLY EQUIVALENT 18
ENCORE MEDICAL CORPORATION
  1
  SUBSTANTIALLY EQUIVALENT 16
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 12
FOURNITURES HOSPITALIERES INDUSTRIE
  SUBSTANTIALLY EQUIVALENT 2
IMPLEX
  SUBSTANTIALLY EQUIVALENT 1
MATERIALISE N.V.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 7
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 5
SULZER
  SUBSTANTIALLY EQUIVALENT 5
TORNIER
  SUBSTANTIALLY EQUIVALENT 33
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 10

Device Problems
No Information 438
Implant, removal of 339
No Known Device Problem 316
Dislodged or dislocated 284
Loose 127
Fracture 112
Dislocated 84
Naturally worn 83
Loss of or failure to bond 81
Break 61
Migration of device or device component 60
Loose or intermittent connection 59
Disassembly 52
Unknown (for use when the device problem is not known) 51
Loss of osseointegration 47
Unstable 46
Other (for use when an appropriate device code cannot be identified) 43
Component(s), worn 41
Device operates differently than expected 38
No code available 34
Device remains implanted 33
Mechanical issue 32
Malfunction 29
Malposition of device 24
Slippage of device or device component 24
Fitting problem 24
Difficult to insert 24
Detachment of device component 19
Material integrity issue 17
Explanted 15
Size incorrect for patient 15
Material separation 14
Noise, Audible 11
Component(s), broken 9
Bent 8
Positioning Issue 8
Device or device component damaged by another device 7
Improper or incorrect procedure or method 7
Interlock(s), failure of 6
Metal shedding debris 6
Disengaged 6
Detachment of device or device component 6
Device-device incompatibility 6
Torn material 6
Material deformation 5
Failure to Adhere or Bond 5
Material erosion 5
Connection issue 5
Human-Device Interface Issue 4
Component or accessory incompatibility 4
Packaging issue 4
Defective component 3
Device Issue 3
Difficult to position 3
Crack 3
Degraded 3
Entrapment of device or device component 2
Device Cleaning Issue 2
User used incorrect product for intended use 2
Unintended collision 2
Device abrasion from instrument or another object 2
Tear, rip or hole in device packaging 2
Patient-device incompatibility 2
Device inoperable 2
Use of Device Issue 2
Difficult to remove 2
Scratched material 2
Material Distortion 2
Mechanical jam 2
Mechanics altered 1
Osseointegration issue 1
Incorrect device or component shipped 1
Device packaging compromised 1
Difficult to open or close 1
Extrusion 1
Unintended movement 1
Not Applicable 1
Material rupture 1
Device, or device fragments remain in patient 1
Sticking 1
Tip breakage 1
Deployment issue 1
Failure to align 1
Failure to advance 1
Failure to separate 1
Dull 1
Component missing 1
Incomplete or missing packaging 1
Delivered as unsterile product 1
Material opacification 1
Material fragmentation 1
Device maintenance issue 1
Incorrect measurement 1
Component falling 1
Contamination during use 1
Material disintegration 1
Disconnection 1
Total Device Problems 2853

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 5 1 4 3 2 2 1 1 3 3 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Feb-24-2015
2 Biomet, Inc. II Jan-09-2013
3 Biomet, Inc. II Jun-09-2011
4 Biomet, Inc. II Dec-16-2010
5 Depuy Orthopaedics, Inc. II Jan-15-2009
6 Depuy Orthopaedics, Inc. II Nov-17-2007
7 Encore Medical, Lp II Jul-06-2011
8 Encore Medical, Lp II Dec-22-2010
9 Encore Medical, Lp II Dec-19-2007
10 Encore Medical, Lp II Sep-25-2007
11 Exactech, Inc. II Apr-20-2015
12 Exactech, Inc. II Jul-31-2012
13 Integra LifeSciences Corp. II Nov-08-2014
14 Limacorporate S.p.A II May-25-2016
15 Smith & Nephew Inc II Apr-07-2010
16 Smith & Nephew Inc II Feb-03-2009
17 Stryker Howmedica Osteonics Corp. II Aug-10-2015
18 Stryker Howmedica Osteonics Corp. II Jan-26-2009
19 Stryker Howmedica Osteonics Corp. II Jun-26-2008
20 Stryker Howmedica Osteonics Corp. II Nov-01-2007
21 Tornier, Inc II Dec-03-2016
22 Tournier, Inc. II Jan-23-2009
23 Zimmer Gmbh II Jun-16-2016
24 Zimmer Inc. II Aug-23-2007
25 Zimmer, Inc. II Nov-06-2012

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