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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
Regulation Description Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
Product CodeMAY
Regulation Number 888.3353
Device Class 2

MDR Year MDR Reports MDR Events
2020 14 15
2021 24 24
2022 11 11
2023 8 9
2024 8 8
2025 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 29 29
Break 14 14
Adverse Event Without Identified Device or Use Problem 8 9
Device Dislodged or Dislocated 6 7
Naturally Worn 6 6
Unstable 4 4
Material Deformation 3 3
Tear, Rip or Hole in Device Packaging 3 3
Migration 3 3
Device Contaminated During Manufacture or Shipping 2 2
Packaging Problem 2 2
Loss of or Failure to Bond 2 2
Noise, Audible 2 3
Mechanical Problem 1 1
Physical Resistance/Sticking 1 1
Patient-Device Incompatibility 1 1
Insufficient Information 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Degraded 1 1
Difficult to Insert 1 1
Unraveled Material 1 1
Detachment of Device or Device Component 1 1
Appropriate Term/Code Not Available 1 1
Material Too Soft/Flexible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 26 26
Failure of Implant 13 13
Pain 10 11
Insufficient Information 7 8
Bone Fracture(s) 6 6
No Patient Involvement 6 6
Joint Dislocation 4 4
Unspecified Infection 3 3
Osteopenia/ Osteoporosis 3 3
No Known Impact Or Consequence To Patient 3 3
Unequal Limb Length 2 2
Scar Tissue 2 2
Malunion of Bone 2 2
Swelling/ Edema 2 2
High Blood Pressure/ Hypertension 1 2
Sleep Dysfunction 1 2
Hypersensitivity/Allergic reaction 1 2
Emotional Changes 1 2
Hearing Loss 1 2
Sepsis 1 1
No Code Available 1 1
Metal Related Pathology 1 1
Memory Loss/Impairment 1 2
Necrosis 1 1
Atrial Fibrillation 1 2
Blood Loss 1 1
Electrolyte Imbalance 1 1
Post Operative Wound Infection 1 1
Foreign Body In Patient 1 1
Swelling 1 1
Fall 1 1
Toxicity 1 2
Headache 1 2
Hemorrhage/Bleeding 1 1
Tinnitus 1 2
Arthritis 1 2
Tissue Breakdown 1 1
Hypovolemia 1 1
Ambulation Difficulties 1 1

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