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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device prosthesis, hip, hemi-, femoral, metal ball
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 79 79
2021 59 59
2022 60 60

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 229 229
Insufficient Information 89 89
Device Dislodged or Dislocated 51 51
Appropriate Term/Code Not Available 8 8
Naturally Worn 6 6
Migration 3 3
Break 3 3
Inadequacy of Device Shape and/or Size 2 2
Device Contaminated During Manufacture or Shipping 2 2
Material Deformation 2 2
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 162 162
No Code Available 141 141
Pain 122 122
Joint Dislocation 53 53
Not Applicable 23 23
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 21 21
No Clinical Signs, Symptoms or Conditions 9 9
Joint Laxity 7 7
No Information 6 6
Discomfort 6 6
Hematoma 6 6
Foreign Body Reaction 5 5
Fall 4 4
Injury 4 4
Fluid Discharge 4 4
Post Operative Wound Infection 2 2
Insufficient Information 2 2
Tissue Damage 2 2
No Consequences Or Impact To Patient 2 2
Failure of Implant 2 2
Wound Dehiscence 1 1
Adhesion(s) 1 1
Erosion 1 1
Cardiac Arrest 1 1
Stroke/CVA 1 1
Embolism 1 1
Joint Disorder 1 1
Phlebitis 1 1
Pneumonia 1 1
Pocket Erosion 1 1
Seroma 1 1
Thrombosis 1 1
Test Result 1 1
Heart Failure/Congestive Heart Failure 1 1

Recalls
Manufacturer Recall Class Date Posted
1 DePuy Orthopaedics, Inc. II Jul-12-2022
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