• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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 270
Dislodged or dislocated 220
Implant, removal of 157
Fitting problem 110
No code available 69
Fracture 62
Break 60
Dislocated 51
Device remains implanted 50
Unknown (for use when the device problem is not known) 50
Loose 48
Disassembly 44
Loss of osseointegration 43
Explanted 34
Migration of device or device component 32
Difficult to insert 28
Component(s), worn 26
Malfunction 26
Naturally worn 24
Other (for use when an appropriate device code cannot be identified) 24
No Known Device Problem 23
Failure to Adhere or Bond 21
Malposition of device 20
Loose or intermittent connection 19
Detachment of device component 17
Disengaged 15
Difficult to remove 15
Loss of or failure to bond 13
Couple, failure to 8
Size incorrect for patient 7
Unstable 7
Tear, rip or hole in device packaging 7
Device operates differently than expected 7
Device markings issue 6
Device, or device fragments remain in patient 5
Incompatibility problem 4
Interlock(s), failure of 3
Slippage of device or device component 3
Component(s), broken 3
Component incompatible 2
Mechanical issue 2
Metal shedding debris 2
Unsealed device packaging 2
Detachment of device or device component 2
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
Premature end-of-life indicator 1
Misassembled 1
Material separation 1
Sterility 1
Use of Device Issue 1
Entrapment of device or device component 1
Total Device Problems 1657

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

-
-