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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

MDR Year MDR Reports MDR Events
2017 336 336
2018 206 206
2019 140 140
2020 94 94
2021 64 64

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 550 550
Device Dislodged or Dislocated 63 63
Corroded 56 56
Material Disintegration 49 49
Break 24 24
Appropriate Term/Code Not Available 23 23
Loose or Intermittent Connection 21 21
Material Erosion 17 17
Detachment of Device or Device Component 13 13
Naturally Worn 12 12
Loss of Osseointegration 12 12
Adverse Event Without Identified Device or Use Problem 11 11
Fracture 10 10
Unstable 9 9
Migration or Expulsion of Device 8 8
Noise, Audible 8 8
Malposition of Device 7 7
Metal Shedding Debris 4 4
Mechanical Problem 3 3
Compatibility Problem 3 3
Migration 3 3
Fitting Problem 2 2
Patient-Device Incompatibility 2 2
Unsealed Device Packaging 1 1
Difficult to Remove 1 1
Material Fragmentation 1 1
Difficult to Insert 1 1
Computer Software Problem 1 1
Degraded 1 1
Disassembly 1 1
Material Distortion 1 1
Material Twisted/Bent 1 1
Patient Device Interaction Problem 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Packaging Problem 1 1
Positioning Problem 1 1
Device-Device Incompatibility 1 1
Device Contamination with Chemical or Other Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Reaction 410 410
Pain 177 177
No Information 171 171
Unspecified Infection 58 58
Metal Related Pathology 40 40
No Code Available 17 17
Joint Dislocation 17 17
Osteolysis 16 16
Insufficient Information 15 15
Failure of Implant 12 12
Tissue Damage 11 11
Injury 10 10
Bone Fracture(s) 10 10
Loss of Range of Motion 8 8
Host-Tissue Reaction 7 7
Foreign Body Reaction 5 5
Necrosis 5 5
Swelling 4 4
Synovitis 4 4
Unequal Limb Length 4 4
Unspecified Tissue Injury 3 3
Osteopenia/ Osteoporosis 3 3
Limited Mobility Of The Implanted Joint 3 3
Fluid Discharge 3 3
No Known Impact Or Consequence To Patient 3 3
Hip Fracture 3 3
Toxicity 3 3
Ossification 3 3
Local Reaction 3 3
Inflammation 3 3
Keratitis 2 2
Wound Dehiscence 2 2
Calcium Deposits/Calcification 2 2
Discomfort 2 2
Sleep Dysfunction 2 2
Ambulation Difficulties 2 2
Inadequate Osseointegration 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
No Clinical Signs, Symptoms or Conditions 1 1
Device Embedded In Tissue or Plaque 1 1
Impaired Healing 1 1
Neck Stiffness 1 1
Tentorial Tears 1 1
Thrombosis 1 1
Urinary Tract Infection 1 1
No Consequences Or Impact To Patient 1 1
Cardiac Arrest 1 1
Death 1 1
Edema 1 1
Adhesion(s) 1 1
Hypersensitivity/Allergic reaction 1 1
Scar Tissue 1 1
Sepsis 1 1

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