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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 483
Dislodged or dislocated 397
Implant, removal of 157
Fitting problem 120
No code available 94
Break 87
Fracture 82
Disassembly 72
Loss of osseointegration 68
No Known Device Problem 52
Migration of device or device component 52
Dislocated 51
Device remains implanted 50
Unknown (for use when the device problem is not known) 50
Loose 48
Explanted 34
Naturally worn 34
Failure to Adhere or Bond 33
Difficult to insert 32
Malposition of device 32
Unstable 27
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 12
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
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
Misassembled 2
Unsealed device packaging 2
Mechanical jam 2
Connection issue 2
Failure to advance 2
Incomplete or missing packaging 2
Component missing 2
Out-of-box failure 1
Dull 1
Labeling, missing 1
Split 1
Failure to separate 1
Defective item 1
Device-device incompatibility 1
Osseointegration issue 1
Torn material 1
Noise, Audible 1
Difficult to position 1
Premature end-of-life indicator 1
Use of Device Issue 1
Sterility 1
Bent 1
Entrapment of device or device component 1
Material fragmentation 1
Total Device Problems 2347

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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