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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 75
Component or accessory incompatibility 47
Difficult to insert 34
Dislodged or dislocated 21
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 6
Fitting problem 4
Accessory incompatible 3
Device operates differently than expected 2
No Known Device Problem 2
Positioning Issue 2
Malposition of device 2
Detachment of device or device component 2
Difficult to remove 2
Size incorrect for patient 1
Sticking 1
Metal shedding debris 1
Delivered as unsterile product 1
Unsealed device packaging 1
Device markings issue 1
Device damaged prior to use 1
Corrosion 1
Scratched material 1
Item contaminated during manufacturing or shipping 1
Difficult to open or remove packaging material 1
Total Device Problems 291

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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