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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
No Information 64
Fracture 39
Dislodged or dislocated 29
Difficult to insert 22
Migration of device or device component 14
Difficult to position 8
Unstable 8
Device-device incompatibility 8
Detachment of device component 7
Fitting problem 6
Material erosion 5
Mechanical issue 4
Disassembly 4
Malposition of device 4
Naturally worn 3
Packaging issue 3
Noise, Audible 3
No code available 2
Patient-device incompatibility 2
Component or accessory incompatibility 2
Break 2
Metal shedding debris 2
User used incorrect product for intended use 2
Misassembled 1
Delivered as unsterile product 1
Unsealed device packaging 1
Failure to Adhere or Bond 1
Bent 1
Device operates differently than expected 1
Device or device component damaged by another device 1
Device damaged prior to use 1
Defective component 1
Incomplete or missing packaging 1
Failure to align 1
Scratched material 1
No Known Device Problem 1
Incompatibility problem 1
Material deformation 1
Total Device Problems 258

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 1
Class II 0 0 0 0 0 0 1 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Jun-17-2013
2 Zimmer Biomet, Inc. I Feb-11-2017

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