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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/ceramic/polymer, cemented or non-porous cemented, osteophilic finish
Product CodeMAY
Regulation Number 888.3353
Device Class 2

MDR Year MDR Reports MDR Events
2018 33 33
2019 11 11
2020 14 14
2021 24 24
2022 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 29 29
Adverse Event Without Identified Device or Use Problem 13 13
Device Dislodged or Dislocated 9 9
Break 7 7
Insufficient Information 7 7
Naturally Worn 5 5
Tear, Rip or Hole in Device Packaging 5 5
Device Contaminated During Manufacture or Shipping 5 5
Migration 4 4
Appropriate Term/Code Not Available 4 4
Noise, Audible 3 3
Unstable 3 3
Material Fragmentation 3 3
Device-Device Incompatibility 2 2
Packaging Problem 2 2
Loss of or Failure to Bond 2 2
Detachment of Device or Device Component 2 2
Mechanical Problem 2 2
Difficult to Insert 2 2
Loose or Intermittent Connection 1 1
Unraveled Material 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Difficult To Position 1 1
Crack 1 1
Degraded 1 1
Material Too Soft/Flexible 1 1
Detachment Of Device Component 1 1
Physical Resistance/Sticking 1 1
Material Deformation 1 1
Migration or Expulsion of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 17 17
Joint Dislocation 15 15
Unspecified Infection 14 14
Pain 14 14
Failure of Implant 12 12
No Patient Involvement 11 11
No Information 9 9
Bone Fracture(s) 6 6
No Code Available 4 4
No Known Impact Or Consequence To Patient 4 4
Insufficient Information 4 4
Swelling/ Edema 3 3
Malunion of Bone 2 2
Swelling 2 2
Ambulation Difficulties 2 2
Osteopenia/ Osteoporosis 2 2
Unequal Limb Length 2 2
Scar Tissue 2 2
Blood Loss 2 2
Synovitis 1 1
Reaction 1 1
Atrial Fibrillation 1 1
Headache 1 1
Memory Loss/Impairment 1 1
Sepsis 1 1
Toxicity 1 1
Numbness 1 1
Sleep Dysfunction 1 1
Emotional Changes 1 1
High Blood Pressure/ Hypertension 1 1
Hypovolemia 1 1
Arthritis 1 1
Fall 1 1
Hearing Loss 1 1
Hypersensitivity/Allergic reaction 1 1
Necrosis 1 1
Local Reaction 1 1
Tinnitus 1 1
Limited Mobility Of The Implanted Joint 1 1

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