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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 82
Unstable 25
Implant, removal of 23
Migration of device or device component 14
Malposition of device 14
Dislodged or dislocated 11
Other (for use when an appropriate device code cannot be identified) 11
No Known Device Problem 9
Noise, Audible 8
Size incorrect for patient 6
No code available 5
Mechanical issue 4
Detachment of device component 4
Component incompatible 4
Improper or incorrect procedure or method 3
Unknown (for use when the device problem is not known) 3
Loss of osseointegration 2
Device remains implanted 2
Dislocated 2
Loose 2
Device-device incompatibility 2
Manufacturing or shipping issue associated with device 1
User used incorrect product for intended use 1
Fracture 1
Difficult to insert 1
Component missing 1
Total Device Problems 241

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