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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, shoulder, hemi-, humeral, metallic uncemented
Regulation Description Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.
Product CodeHSD
Regulation Number 888.3690
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCUMED SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 4
ASCENSION ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
BIOMET
  SUBSTANTIALLY EQUIVALENT 7
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 6
ENCORE MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 4
OSTEOIMPLANT TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
PLUS ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 2
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 8
SYNTHES
  SUBSTANTIALLY EQUIVALENT 1
TORNIER
  SUBSTANTIALLY EQUIVALENT 3
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Information 387
Dislodged or dislocated 326
Implant, removal of 157
Fitting problem 115
No code available 84
Break 77
Fracture 71
Loss of osseointegration 59
Disassembly 56
Dislocated 51
Device remains implanted 50
Unknown (for use when the device problem is not known) 50
Loose 48
Migration of device or device component 36
Explanted 34
Difficult to insert 31
Naturally worn 29
No Known Device Problem 28
Malfunction 26
Component(s), worn 26
Failure to Adhere or Bond 25
Other (for use when an appropriate device code cannot be identified) 24
Malposition of device 21
Difficult to remove 21
Unstable 20
Loose or intermittent connection 19
Loss of or failure to bond 18
Detachment of device component 18
Disengaged 15
Size incorrect for patient 11
Device operates differently than expected 9
Couple, failure to 8
Tear, rip or hole in device packaging 7
Device markings issue 6
Incompatibility problem 5
Device, or device fragments remain in patient 5
Slippage of device or device component 3
Material separation 3
Metal shedding debris 3
Interlock(s), failure of 3
Component incompatible 3
Component(s), broken 3
Detachment of device or device component 3
Component missing 2
Mechanical issue 2
Misassembled 2
Unsealed device packaging 2
Difficult to position 1
Premature end-of-life indicator 1
Use of Device Issue 1
Sterility 1
Entrapment of device or device component 1
Material fragmentation 1
Out-of-box failure 1
Incomplete or missing packaging 1
Connection issue 1
Labeling, missing 1
Split 1
Defective item 1
Material integrity issue 1
Device-device incompatibility 1
Osseointegration issue 1
Torn material 1
Total Device Problems 2018

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 2 0 0 0 2 0 2 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Acumed LLC II Dec-11-2008
2 Arthrosurface, Inc. II Feb-12-2015
3 Limacorporate S.p.A II Sep-02-2015
4 Stryker Howmedica Osteonics Corp. II Jan-26-2009
5 Synvasive Technology Inc II Apr-17-2013
6 Zimmer Inc. II Nov-12-2009
7 Zimmer, Inc. II Jul-10-2013

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