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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 681
Dislodged or dislocated 452
Implant, removal of 157
Break 135
No code available 129
Fitting problem 123
Fracture 103
Loss of osseointegration 85
Disassembly 80
Migration of device or device component 76
No Known Device Problem 56
Dislocated 51
Device remains implanted 50
Unknown (for use when the device problem is not known) 50
Loose 48
Difficult to insert 36
Naturally worn 36
Explanted 34
Failure to Adhere or Bond 34
Unstable 32
Malposition of device 32
Detachment of device component 28
Loss of or failure to bond 27
Component(s), worn 26
Malfunction 26
Other (for use when an appropriate device code cannot be identified) 24
Difficult to remove 23
Loose or intermittent connection 20
Disengaged 15
Size incorrect for patient 14
Metal shedding debris 10
Device operates differently than expected 9
Couple, failure to 8
Material separation 7
Tear, rip or hole in device packaging 7
Detachment of device or device component 6
Device markings issue 6
Mechanical jam 6
Incompatibility problem 5
Device, or device fragments remain in patient 5
Mechanical issue 5
Misconnection 5
Bent 4
Osseointegration issue 4
Connection issue 4
Interlock(s), failure of 3
Defective component 3
Component(s), broken 3
Component incompatible 3
Slippage of device or device component 3
Misassembled 2
Unsealed device packaging 2
Device abrasion from instrument or another object 2
Crack 2
Material erosion 2
Component missing 2
Incomplete or missing packaging 2
Failure to advance 2
Dull 2
Scratched material 2
Torn material 1
Noise, Audible 1
Delamination 1
Device misassembled during manufacturing or shipping 1
Device-device incompatibility 1
Packaging issue 1
Incorrect device or component shipped 1
Material deformation 1
Labeling, missing 1
Split 1
Failure to separate 1
Defective item 1
Out-of-box failure 1
Use of Device Issue 1
Material fragmentation 1
Entrapment of device or device component 1
Decoupling 1
Particulates 1
Peeled 1
Pitted 1
Difficult to position 1
Premature end-of-life indicator 1
Sterility 1
Total Device Problems 2832

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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