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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


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

MDR Year MDR Reports MDR Events
2020 79 79
2021 59 59
2022 65 65
2023 77 77
2024 76 76
2025 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 312 312
Device Dislodged or Dislocated 36 36
Naturally Worn 9 9
Device Contaminated During Manufacture or Shipping 3 3
Break 2 2
Degraded 2 2
Difficult to Insert 2 2
Fracture 2 2
Off-Label Use 1 1
Material Twisted/Bent 1 1
Material Deformation 1 1
Detachment of Device or Device Component 1 1
Migration 1 1
Appropriate Term/Code Not Available 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 157 157
Pain 95 95
No Code Available 73 73
Joint Dislocation 43 43
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 21 21
Joint Laxity 15 15
No Clinical Signs, Symptoms or Conditions 13 13
Insufficient Information 9 9
Discomfort 8 8
Hematoma 6 6
Foreign Body Reaction 6 6
Unspecified Tissue Injury 5 5
Arthritis 5 5
Fall 4 4
Fluid Discharge 4 4
Post Operative Wound Infection 3 3
Hypersensitivity/Allergic reaction 2 2
Bone Fracture(s) 2 2
Injury 2 2
Pocket Erosion 2 2
Arthralgia 1 1
Failure of Implant 1 1
Metal Related Pathology 1 1
Adhesion(s) 1 1
Muscle Weakness 1 1
Cardiac Arrest 1 1
Thrombosis/Thrombus 1 1
Heart Failure/Congestive Heart Failure 1 1
Hemorrhage/Bleeding 1 1
No Consequences Or Impact To Patient 1 1

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