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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, hip, hemi-, femoral, metal ball
Regulation Description Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
Product CodeLZY
Regulation Number 888.3360
Device Class 2

MDR Year MDR Reports MDR Events
2017 72 72
2018 67 67
2019 59 59
2020 77 77
2021 59 59

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 179 179
Insufficient Information 89 89
Device Dislodged or Dislocated 42 42
Appropriate Term/Code Not Available 8 8
Migration 3 3
Naturally Worn 3 3
Break 3 3
Inadequacy of Device Shape and/or Size 2 2
Device Contaminated During Manufacture or Shipping 2 2
Material Deformation 1 1
Material Twisted/Bent 1 1
Improper or Incorrect Procedure or Method 1 1
Fracture 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 140 140
No Code Available 139 139
Pain 99 99
Joint Dislocation 43 43
Not Applicable 23 23
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 21 21
No Information 6 6
Joint Laxity 6 6
Discomfort 6 6
No Clinical Signs, Symptoms or Conditions 5 5
Fall 4 4
Hematoma 4 4
Failure of Implant 2 2
Foreign Body Reaction 2 2
Injury 2 2
Tissue Damage 2 2
No Consequences Or Impact To Patient 2 2
Insufficient Information 2 2
Post Operative Wound Infection 2 2
Fluid Discharge 2 2
Test Result 1 1
Joint Disorder 1 1
Phlebitis 1 1
Pneumonia 1 1
Seroma 1 1
Thrombosis 1 1
Wound Dehiscence 1 1
Adhesion(s) 1 1
Erosion 1 1
Stroke/CVA 1 1
Embolism 1 1

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