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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 + additive, cemented
Regulation Description Shoulder joint metal/polymer semi-constrained cemented prosthesis.
Definition Total shoulders are indicated for arthritis (osteo-, rheumatoid, traumatic), avascular necrosis, correction of functional deformity, and revision procedures.
Product CodePAO
Regulation Number 888.3660
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMET
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Dislodged or dislocated 8
Fracture 7
No Information 5
Detachment of device component 2
Unstable 2
Metal shedding debris 1
Fitting problem 1
Device operates differently than expected 1
Disassembly 1
Mechanical issue 1
Migration of device or device component 1
No code available 1
Break 1
Total Device Problems 32

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

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Jun-17-2013

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