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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 13361
Appropriate Term/Code Not Available 6382
Adverse Event Without Identified Device or Use Problem 2797
Naturally Worn 2424
Metal Shedding Debris 2107
Device Dislodged or Dislocated 2084
Loss of Osseointegration 1677
Corroded 1227
Material Erosion 1073
Noise, Audible 992
Migration or Expulsion of Device 911
Material Disintegration 859
Fracture 594
Malposition of device 572
Loose or Intermittent Connection 437
Break 311
Biocompatibility 284
Disassembly 228
Unstable 212
Migration 148
Nonstandard device 135
Loss of or Failure to Bond 127
Difficult to Remove 123
Osseointegration Problem 113
Separation Failure 90
Compatibility Problem 82
Mechanical Problem 78
Device Operates Differently Than Expected 76
Device Packaging Compromised 75
Inadequacy of Device Shape and/or Size 64
Loosening of Implant Not Related to Bone-Ingrowth 58
Device Slipped 56
Device Contaminated during manufacture or shipping 54
Tear, Rip or Hole in Device Packaging 51
Positioning Problem 50
Packaging Problem 49
Failure To Adhere Or Bond 46
Use of Device Problem 46
Patient-Device Incompatibility 45
Device-Device Incompatibility 44
Degraded 43
Device Contamination with Chemical or Other Material 42
Fitting Problem 41
Failure to Osseointegrate 41
Separation Problem 38
Material Separation 37
Detachment of Device or device Component 34
Difficult to Insert 33
Material Deformation 33
No Apparent Adverse Event 33
Material Integrity Problem 29
Detachment Of Device Component 24
Delivered as Unsterile Product 19
Disconnection 18
Unintended Movement 17
Difficult To Position 16
Component Missing 16
Material Discolored 16
Scratched Material 14
Mechanical Jam 13
Device Markings / Labelling Problem 12
Defective Device 12
Device Issue 11
Component or Accessory Incompatibility 10
Problem with Sterilization 10
Screw 10
Failure to Disconnect 9
Crack 8
Implant, removal of 7
Unsealed Device Packaging 7
Positioning Failure 6
Peeled / Delaminated 6
Cups 6
Material Twisted / Bent 5
Shipping Damage or Problem 5
Off-Label Use 5
Flaked 5
Entrapment of Device 5
Failure to Align 4
Material Protrusion / Extrusion 4
Bent 4
Improper or Incorrect Procedure or Method 4
Defective Component 3
Product Quality Problem 3
Difficult or Delayed Separation 3
Connection Problem 3
Biofilm coating in Device 3
Device Damaged by Another Device 3
Material Fragmentation 3
Physical Resistance / Sticking 3
Fluid Leak 3
Collapse 3
Device Or Device Fragments Location Unknown 2
Material Rupture 2
Dull, Blunt 2
Ambient Noise Problem 2
Manufacturing, Packaging or Shipping Problem 2
Component Incompatible 2
Computer Operating System Problem 2
Misassembled 2
Total Device Problems 40900

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Feb-17-2015
2 DePuy Orthopaedics, Inc. II Jul-21-2014
3 Encore Medical, Lp II Feb-11-2017
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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