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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 3
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

Device Problems
No Information 331
Dislodged or dislocated 268
Implant, removal of 157
Fitting problem 113
No code available 74
Fracture 65
Break 63
Dislocated 51
Disassembly 50
Device remains implanted 50
Unknown (for use when the device problem is not known) 50
Loose 48
Loss of osseointegration 47
Migration of device or device component 34
Explanted 34
Difficult to insert 30
Naturally worn 29
No Known Device Problem 27
Malfunction 26
Component(s), worn 26
Other (for use when an appropriate device code cannot be identified) 24
Malposition of device 21
Failure to Adhere or Bond 21
Loose or intermittent connection 19
Difficult to remove 19
Detachment of device component 17
Loss of or failure to bond 15
Disengaged 15
Unstable 12
Size incorrect for patient 9
Couple, failure to 8
Tear, rip or hole in device packaging 7
Device operates differently than expected 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
Component(s), broken 3
Interlock(s), failure of 3
Detachment of device or device component 3
Component incompatible 2
Metal shedding debris 2
Unsealed device packaging 2
Mechanical issue 2
Misassembled 1
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
Connection issue 1
Labeling, missing 1
Split 1
Defective item 1
Component missing 1
Out-of-box failure 1
Incomplete or missing packaging 1
Material integrity issue 1
Osseointegration issue 1
Torn material 1
Total Device Problems 1823

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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