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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, shoulder, semi-constrained, metal/polymer, uncemented
Regulation Description Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis.
Product CodeMBF
Regulation Number 888.3670
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMET
  SUBSTANTIALLY EQUIVALENT 7
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 4
ENCORE MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Information 48
Implant, removal of 23
Malposition of device 13
Other (for use when an appropriate device code cannot be identified) 11
Dislodged or dislocated 7
Migration of device or device component 6
Size incorrect for patient 5
No code available 5
Component incompatible 4
Detachment of device component 3
Unknown (for use when the device problem is not known) 3
Loss of osseointegration 2
Loose 2
Dislocated 2
Device remains implanted 2
Unstable 1
Fracture 1
Manufacturing or shipping issue associated with device 1
No Known Device Problem 1
Total Device Problems 140

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

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. III Jun-11-2015
2 Encore Medical, Lp II Sep-04-2009

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