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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 13558
Appropriate Term/Code Not Available 6443
Adverse Event Without Identified Device or Use Problem 4478
Naturally Worn 3851
Device Dislodged or Dislocated 2551
Metal Shedding Debris 2117
Loss of Osseointegration 1977
Corroded 1310
Material Erosion 1130
Noise, Audible 1069
Migration or Expulsion of Device 913
Material Disintegration 866
Fracture 672
Malposition of device 627
Loose or Intermittent Connection 446
Break 317
Biocompatibility 288
Migration 244
Osseointegration Problem 228
Disassembly 228
Unstable 225
Loss of or Failure to Bond 193
Use of Device Problem 180
Nonstandard device 135
Difficult to Remove 130
Device Contaminated during manufacture or shipping 100
Separation Failure 93
Compatibility Problem 82
Mechanical Problem 79
Loosening of Implant Not Related to Bone-Ingrowth 78
Inadequacy of Device Shape and/or Size 77
Device Operates Differently Than Expected 76
Device Packaging Compromised 75
Degraded 69
Positioning Problem 64
Packaging Problem 63
Tear, Rip or Hole in Device Packaging 61
Failure to Osseointegrate 56
Device Slipped 56
Device-Device Incompatibility 48
Patient-Device Incompatibility 47
Failure To Adhere Or Bond 47
Fitting Problem 43
Device Contamination with Chemical or Other Material 42
Detachment of Device or device Component 40
Difficult to Insert 39
Material Separation 39
Separation Problem 38
No Apparent Adverse Event 34
Material Deformation 34
Material Integrity Problem 29
Unintended Movement 26
Detachment Of Device Component 24
Delivered as Unsterile Product 19
Disconnection 18
Scratched Material 16
Material Discolored 16
Component Missing 16
Difficult To Position 16
Defective Device 13
Mechanical Jam 13
Device Markings / Labelling Problem 12
Device Issue 11
Component or Accessory Incompatibility 10
Screw 10
Problem with Sterilization 10
Positioning Failure 10
Failure to Disconnect 9
Crack 8
Material Twisted / Bent 8
Implant, removal of 7
Unsealed Device Packaging 7
Difficult or Delayed Separation 6
Flaked 6
Off-Label Use 6
Peeled / Delaminated 6
Cups 6
Shipping Damage or Problem 5
Entrapment of Device 5
Material Protrusion / Extrusion 4
Improper or Incorrect Procedure or Method 4
Failure to Align 4
Bent 4
Product Quality Problem 3
Fluid Leak 3
Device Damaged by Another Device 3
Defective Component 3
Material Fragmentation 3
Collapse 3
Physical Resistance / Sticking 3
Biofilm coating in Device 3
Connection Problem 3
Expiration Date Error 2
Incomplete or Missing Packaging 2
Particulates 2
Manufacturing, Packaging or Shipping Problem 2
Delamination 2
Material Rupture 2
Device Or Device Fragments Location Unknown 2
Ambient Noise Problem 2
Total Device Problems 46063

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 Nov-07-2019
5 Zimmer Biomet, Inc. II Dec-19-2018
6 Zimmer Biomet, Inc. II Aug-14-2018
7 Zimmer Biomet, Inc. II Dec-29-2017
8 Zimmer Biomet, Inc. II Feb-22-2016
9 Zimmer Gmbh II Feb-20-2015
10 Zimmer, Inc. I Jun-08-2015

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