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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 8
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 15
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 32
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 10

Device Problems
Implant, removal of 339
No Information 264
Dislodged or dislocated 209
No Known Device Problem 165
Loose 127
Fracture 92
Dislocated 84
Naturally worn 77
Loss of or failure to bond 63
Loose or intermittent connection 57
Break 53
Unknown (for use when the device problem is not known) 51
Other (for use when an appropriate device code cannot be identified) 43
Component(s), worn 41
Loss of osseointegration 39
Disassembly 36
Device operates differently than expected 35
Device remains implanted 33
No code available 32
Migration of device or device component 29
Malfunction 29
Slippage of device or device component 24
Unstable 21
Fitting problem 18
Malposition of device 18
Explanted 15
Size incorrect for patient 14
Mechanical issue 12
Difficult to insert 10
Material separation 10
Material integrity issue 10
Component(s), broken 9
Detachment of device component 8
Disengaged 6
Metal shedding debris 6
Interlock(s), failure of 6
Improper or incorrect procedure or method 5
Failure to Adhere or Bond 5
Torn material 5
Packaging issue 4
Positioning Issue 4
Noise, Audible 3
Bent 3
Crack 3
Connection issue 3
Detachment of device or device component 3
Patient-device incompatibility 2
Tear, rip or hole in device packaging 2
Device-device incompatibility 2
Human-Device Interface Issue 2
Use of Device Issue 2
Device inoperable 2
Defective component 2
Degraded 2
Entrapment of device or device component 2
Unintended collision 2
Difficult to remove 2
Device abrasion from instrument or another object 2
Incorrect measurement 1
Material fragmentation 1
Material rupture 1
Delivered as unsterile product 1
Material opacification 1
Device, or device fragments remain in patient 1
Disconnection 1
Contamination during use 1
Component falling 1
Component missing 1
Incomplete or missing packaging 1
Device Issue 1
Sticking 1
Tip breakage 1
Incorrect device or component shipped 1
Material deformation 1
Material Distortion 1
Difficult to open or close 1
Device packaging compromised 1
Failure to advance 1
Unintended movement 1
Scratched material 1
Mechanical jam 1
Extrusion 1
Total Device Problems 2171

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 5 1 4 3 2 2 1 1 3 1
Class III 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 Tournier, Inc. II Jan-23-2009
22 Zimmer Inc. II Aug-23-2007
23 Zimmer, Inc. II Nov-06-2012

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