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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
2019 11 11
2020 14 14
2021 24 24
2022 11 11
2023 8 8
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 27 27
Break 9 9
Device Dislodged or Dislocated 6 6
Adverse Event Without Identified Device or Use Problem 6 6
Device Contaminated During Manufacture or Shipping 5 5
Tear, Rip or Hole in Device Packaging 5 5
Naturally Worn 5 5
Unstable 4 4
Material Fragmentation 3 3
Noise, Audible 3 3
Migration 3 3
Material Deformation 2 2
Loss of or Failure to Bond 2 2
Packaging Problem 2 2
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Detachment of Device or Device Component 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Crack 1 1
Degraded 1 1
Difficult to Insert 1 1
Loose or Intermittent Connection 1 1
Mechanical Problem 1 1
Unraveled Material 1 1
Material Too Soft/Flexible 1 1
Physical Resistance/Sticking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 20 20
Failure of Implant 13 13
No Patient Involvement 11 11
Pain 8 8
Insufficient Information 6 6
Joint Dislocation 6 6
Bone Fracture(s) 6 6
No Known Impact Or Consequence To Patient 4 4
Osteopenia/ Osteoporosis 3 3
Unspecified Infection 3 3
Unequal Limb Length 2 2
No Information 2 2
Swelling/ Edema 2 2
Scar Tissue 2 2
Malunion of Bone 2 2
Foreign Body In Patient 1 1
No Code Available 1 1
Swelling 1 1
Arthritis 1 1
Tissue Breakdown 1 1
Sleep Dysfunction 1 1
Emotional Changes 1 1
Sepsis 1 1
Local Reaction 1 1
Necrosis 1 1
Tinnitus 1 1
Hypersensitivity/Allergic reaction 1 1
Hearing Loss 1 1
Fall 1 1
Hypovolemia 1 1
Headache 1 1
Blood Loss 1 1
Atrial Fibrillation 1 1
Toxicity 1 1
Memory Loss/Impairment 1 1
High Blood Pressure/ Hypertension 1 1
Metal Related Pathology 1 1
Ambulation Difficulties 1 1

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