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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive
Regulation Description Hip joint metal/polymer constrained cemented or uncemented prosthesis.
Definition For use as a component of a total hip prosthesis in primary and revision patients at high risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability, and for whom all other options to constrained acetabular components have been considered.
Product CodePBI
Regulation Number 888.3310
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMET
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Fracture 79
Component or accessory incompatibility 47
Difficult to insert 35
Dislodged or dislocated 22
No Information 18
Packaging issue 14
Device-device incompatibility 12
Migration of device or device component 12
Break 12
Device packaging compromised 10
Failure to separate 8
Fitting problem 4
Malposition of device 3
Accessory incompatible 3
Device operates differently than expected 2
No Known Device Problem 2
Positioning Issue 2
Noise, Audible 2
Detachment of device or device component 2
Detachment of device component 2
Delivered as unsterile product 2
Unsealed device packaging 2
Difficult to remove 2
Size incorrect for patient 1
Sticking 1
Metal shedding debris 1
Corrosion 1
Device damaged prior to use 1
Device markings issue 1
Scratched material 1
Item contaminated during manufacturing or shipping 1
Material deformation 1
Difficult to open or remove packaging material 1
Total Device Problems 307

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 0 0 0 0 0 1 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-19-2014

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