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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 cemented acetabular component)
Regulation Description Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis.
Product CodeJDL
Regulation Number 888.3320
Device Class 3

Device Problems
Insufficient Information 767
Device Dislodged or Dislocated 62
Corroded 38
Loose or Intermittent Connection 33
Material Disintegration 20
Break 19
Material Erosion 16
Naturally Worn 15
Metal Shedding Debris 14
Adverse Event Without Identified Device or Use Problem 13
Noise, Audible 12
Migration or Expulsion of Device 11
Unstable 10
Appropriate Term/Code Not Available 10
Fracture 8
Malposition of device 5
Device Slipped 5
Detachment of Device or device Component 5
Device Operates Differently Than Expected 4
Loss of Osseointegration 3
Inadequacy of Device Shape and/or Size 3
Difficult to Remove 3
Migration 2
Material Separation 2
Packaging Problem 2
Positioning Problem 2
Disassembly 2
Material Twisted / Bent 1
Loosening of Implant Not Related to Bone-Ingrowth 1
Component Incompatible 1
Compatibility Problem 1
Material Integrity Problem 1
Computer Software Problem 1
Device Contamination with Chemical or Other Material 1
Fitting Problem 1
Cups 1
Detachment Of Device Component 1
Material Distortion 1
Unsealed Device Packaging 1
No Apparent Adverse Event 1
Degraded 1
Device Markings / Labelling Problem 1
Patient-Device Incompatibility 1
Delamination 1
Material Frayed 1
Total Device Problems 1104

Recalls
Manufacturer Recall Class Date Posted
1 Wright Medical Technology Inc II Jun-25-2015

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