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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, elbow, hemi-, radial, polymer
Regulation Description Elbow joint radial (hemi-elbow) polymer prosthesis.
Product CodeKWI
Regulation Number 888.3170
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCUMED SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ASCENSION ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
AVANTA
  SUBSTANTIALLY EQUIVALENT 4
BIOMET
  SUBSTANTIALLY EQUIVALENT 3
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 1
IMPLEX
  SUBSTANTIALLY EQUIVALENT 1
KINETIKOS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
TORNIER
  SUBSTANTIALLY EQUIVALENT 1
WRIGHT MEDICAL TECHNOLOGY, INC.
  1
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Unintended movement 27
Loose or intermittent connection 14
Unknown (for use when the device problem is not known) 12
Implant, removal of 9
No Known Device Problem 9
Migration of device or device component 8
Break 6
Device operates differently than expected 6
No code available 4
Detachment of device component 4
Explanted 3
Fracture 3
Component(s), broken 3
No Information 3
Dislodged or dislocated 2
Material integrity issue 2
Displacement 2
Fitting problem 2
Device Issue 2
Internal fixation, revision of 2
Malposition of device 2
Failure to Adhere or Bond 2
Difficult to insert 2
Size incorrect for patient 2
Slippage of device or device component 1
Metal shedding debris 1
Improper or incorrect procedure or method 1
Misassembled 1
Material rupture 1
Loose 1
Material discolored 1
Loss of or failure to bond 1
Connection issue 1
Detachment of device or device component 1
Tear, rip or hole in device packaging 1
Residue after decontamination 1
Packaging issue 1
Total Device Problems 144

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

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II May-13-2014
2 Skeletal Dynamics II Dec-12-2014
3 Small Bone Innovations, Inc. II Oct-29-2013
4 Synthes USA HQ, Inc. II May-03-2013

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