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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, hip, semi-constrained (metal uncemented acetabular component)
Regulation Description Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
Product CodeKWA
Regulation Number 888.3330
Device Class 3

Device Problems
Insufficient Information 12631
Adverse Event Without Identified Device or Use Problem 6882
Appropriate Term/Code Not Available 5511
Naturally Worn 3777
Device Dislodged or Dislocated 2747
Loss of Osseointegration 2159
Metal Shedding Debris 1610
Corroded 1280
Material Erosion 1144
Noise, Audible 948
Migration or Expulsion of Device 819
Fracture 737
Malposition of Device 681
Material Disintegration 626
Osseointegration Problem 510
Device Contaminated During Manufacture or Shipping 489
Loose or Intermittent Connection 422
Migration 386
Use of Device Problem 329
Break 306
Biocompatibility 292
Loss of or Failure to Bond 241
Unstable 232
Degraded 221
Disassembly 209
Difficult to Remove 145
Loosening of Implant Not Related to Bone-Ingrowth 120
Packaging Problem 112
Separation Failure 99
Inadequacy of Device Shape and/or Size 89
Tear, Rip or Hole in Device Packaging 89
Compatibility Problem 78
Device Packaging Compromised 75
Mechanical Problem 70
Device Operates Differently Than Expected 67
Failure to Osseointegrate 63
Unintended Movement 61
Positioning Problem 61
Difficult to Insert 57
Device-Device Incompatibility 57
Detachment of Device or Device Component 51
Patient-Device Incompatibility 47
Fitting Problem 45
Device Contamination with Chemical or Other Material 42
Failure To Adhere Or Bond 40
Device Slipped 38
No Apparent Adverse Event 37
Separation Problem 36
Nonstandard Device 34
Material Separation 30
Material Deformation 29
Positioning Failure 26
Material Integrity Problem 21
Detachment Of Device Component 21
Delivered as Unsterile Product 20
Disconnection 18
Scratched Material 17
Difficult To Position 17
Material Twisted/Bent 16
Mechanical Jam 15
Component Missing 15
Off-Label Use 13
Defective Device 13
Material Discolored 12
Difficult or Delayed Separation 11
Device Markings/Labelling Problem 11
Problem with Sterilization 10
Crack 9
Failure to Disconnect 9
Component or Accessory Incompatibility 9
Device Issue 9
Patient Device Interaction Problem 7
Unsealed Device Packaging 7
Improper or Incorrect Procedure or Method 7
Peeled/Delaminated 6
Screw 6
Cup 6
Flaked 5
Shipping Damage or Problem 5
Connection Problem 5
Implant, removal of 5
Entrapment of Device 5
Expiration Date Error 4
Failure to Align 4
Collapse 4
Bent 4
Fluid Leak 3
Defective Component 3
Manufacturing, Packaging or Shipping Problem 3
Physical Resistance/Sticking 3
Biofilm coating in Device 3
Incomplete or Missing Packaging 2
Particulates 2
Delamination 2
Device Damaged Prior to Use 2
Difficult or Delayed Positioning 2
Material Rupture 2
Device Or Device Fragments Location Unknown 2
Ambient Noise Problem 2
Device Damaged by Another Device 2
Total Device Problems 47266

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Feb-17-2015
2 Encore Medical, Lp II Feb-11-2017
3 Zimmer Biomet, Inc. II Nov-07-2019
4 Zimmer Biomet, Inc. II Dec-19-2018
5 Zimmer Biomet, Inc. II Aug-14-2018
6 Zimmer Biomet, Inc. II Dec-29-2017
7 Zimmer Biomet, Inc. II Feb-22-2016
8 Zimmer Gmbh II Feb-20-2015
9 Zimmer, Inc. I Jun-08-2015

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