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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 549
Dislodged or dislocated 413
Implant, removal of 157
Fitting problem 120
No code available 101
Break 100
Fracture 86
Disassembly 74
Loss of osseointegration 74
Migration of device or device component 65
No Known Device Problem 52
Dislocated 51
Device remains implanted 50
Unknown (for use when the device problem is not known) 50
Loose 48
Difficult to insert 34
Failure to Adhere or Bond 34
Explanted 34
Naturally worn 34
Malposition of device 32
Unstable 28
Detachment of device component 26
Component(s), worn 26
Malfunction 26
Other (for use when an appropriate device code cannot be identified) 24
Loss of or failure to bond 24
Difficult to remove 21
Loose or intermittent connection 19
Disengaged 15
Size incorrect for patient 14
Device operates differently than expected 9
Couple, failure to 8
Tear, rip or hole in device packaging 7
Detachment of device or device component 6
Device markings issue 6
Incompatibility problem 5
Device, or device fragments remain in patient 5
Mechanical issue 4
Metal shedding debris 4
Interlock(s), failure of 3
Material separation 3
Slippage of device or device component 3
Component incompatible 3
Component(s), broken 3
Material erosion 2
Device abrasion from instrument or another object 2
Misassembled 2
Unsealed device packaging 2
Incomplete or missing packaging 2
Component missing 2
Connection issue 2
Failure to advance 2
Mechanical jam 2
Scratched material 2
Torn material 1
Osseointegration issue 1
Noise, Audible 1
Material deformation 1
Device-device incompatibility 1
Labeling, missing 1
Split 1
Failure to separate 1
Defective item 1
Delamination 1
Dull 1
Out-of-box failure 1
Particulates 1
Pitted 1
Difficult to position 1
Premature end-of-life indicator 1
Sterility 1
Use of Device Issue 1
Material fragmentation 1
Entrapment of device or device component 1
Bent 1
Crack 1
Total Device Problems 2492

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 0 1 2 0 0 0 2 0 2 0 0
Class III 0 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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