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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
2016 76 76
2017 72 72
2018 67 67
2019 59 59
2020 77 77
2021 47 47

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 170 170
Insufficient Information 144 144
Device Dislodged or Dislocated 55 55
Appropriate Term/Code Not Available 13 13
Naturally Worn 3 3
Break 3 3
Inadequacy of Device Shape and/or Size 3 3
Migration 2 2
Corroded 1 1
Improper or Incorrect Procedure or Method 1 1
Device Contaminated During Manufacture or Shipping 1 1
Material Deformation 1 1
Disassembly 1 1
Fracture 1 1
Material Twisted/Bent 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 156 156
No Code Available 139 139
Pain 130 130
Joint Dislocation 43 43
Not Applicable 23 23
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 21 21
No Information 20 20
Joint Laxity 6 6
Discomfort 4 4
No Clinical Signs, Symptoms or Conditions 4 4
Fall 4 4
Hematoma 4 4
Host-Tissue Reaction 2 2
Loss of Range of Motion 2 2
No Consequences Or Impact To Patient 2 2
Insufficient Information 2 2
Fluid Discharge 2 2
Injury 2 2
Post Operative Wound Infection 2 2
Foreign Body Reaction 2 2
Tissue Damage 2 2
Adhesion(s) 1 1
Stroke/CVA 1 1
Embolism 1 1
Phlebitis 1 1
Pneumonia 1 1
Seroma 1 1
Test Result 1 1
Joint Disorder 1 1
No Known Impact Or Consequence To Patient 1 1
Ambulation Difficulties 1 1
Wound Dehiscence 1 1
Thrombosis 1 1
Erosion 1 1
Failure of Implant 1 1

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