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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
FOURNITURES HOSPITALIERES INDUSTRIE
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Information 143
Unstable 74
No Known Device Problem 27
Migration of device or device component 25
Implant, removal of 23
Dislodged or dislocated 20
Malposition of device 14
No code available 12
Noise, Audible 11
Other (for use when an appropriate device code cannot be identified) 11
Size incorrect for patient 6
Detachment of device component 5
Component incompatible 4
Mechanical issue 4
Difficult to remove 4
Unknown (for use when the device problem is not known) 3
Improper or incorrect procedure or method 3
Device remains implanted 2
Loose 2
Dislocated 2
Material erosion 2
Fracture 2
Device-device incompatibility 2
Loss of osseointegration 2
Failure to separate 1
Detachment of device or device component 1
Device markings issue 1
Device packaging compromised 1
Manufacturing or shipping issue associated with device 1
Mechanical jam 1
Difficult to insert 1
Disconnection 1
User used incorrect product for intended use 1
Component missing 1
Total Device Problems 413

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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