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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
Product CodeLZY
Regulation Number 888.3360
Device Class 2


Premarket Reviews
ManufacturerDecision
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 59 59
2020 79 79
2021 59 59
2022 65 65
2023 77 77
2024 41 41

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 318 318
Device Dislodged or Dislocated 40 40
Naturally Worn 7 7
Migration 3 3
Device Contaminated During Manufacture or Shipping 3 3
Material Deformation 2 2
Break 2 2
Difficult to Insert 2 2
Inadequacy of Device Shape and/or Size 2 2
Improper or Incorrect Procedure or Method 1 1
Fracture 1 1
Material Twisted/Bent 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 154 154
No Code Available 129 129
Pain 106 106
Joint Dislocation 48 48
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 21 21
Joint Laxity 15 15
No Clinical Signs, Symptoms or Conditions 12 12
Discomfort 8 8
Hematoma 7 7
Foreign Body Reaction 6 6
Insufficient Information 6 6
Fluid Discharge 4 4
Fall 4 4
Unspecified Tissue Injury 3 3
Post Operative Wound Infection 3 3
Injury 3 3
Bone Fracture(s) 2 2
Hypersensitivity/Allergic reaction 2 2
Pocket Erosion 2 2
Seroma 1 1
Thrombosis 1 1
Tissue Damage 1 1
No Consequences Or Impact To Patient 1 1
Failure of Implant 1 1
Muscle Weakness 1 1
Hemorrhage/Bleeding 1 1
Wound Dehiscence 1 1
Adhesion(s) 1 1
Erosion 1 1
Cardiac Arrest 1 1
Stroke/CVA 1 1
Embolism 1 1
Arthralgia 1 1
Phlebitis 1 1
Pneumonia 1 1
Test Result 1 1
Metal Related Pathology 1 1
Thrombosis/Thrombus 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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