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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 57
Implant, removal of 23
Malposition of device 13
Other (for use when an appropriate device code cannot be identified) 11
Migration of device or device component 8
Dislodged or dislocated 7
Size incorrect for patient 5
No code available 5
No Known Device Problem 5
Detachment of device component 4
Component incompatible 4
Unknown (for use when the device problem is not known) 3
Loss of osseointegration 2
Device-device incompatibility 2
Dislocated 2
Unstable 2
Device remains implanted 2
Loose 2
Fracture 1
Difficult to insert 1
Manufacturing or shipping issue associated with device 1
Total Device Problems 160

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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