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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 58 58

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 332 332
Device Dislodged or Dislocated 40 40
Naturally Worn 9 9
Migration 3 3
Device Contaminated During Manufacture or Shipping 3 3
Material Deformation 2 2
Break 2 2
Degraded 2 2
Difficult to Insert 2 2
Inadequacy of Device Shape and/or Size 2 2
Improper or Incorrect Procedure or Method 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Off-Label Use 1 1
Fracture 1 1
Material Twisted/Bent 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 165 165
No Code Available 129 129
Pain 108 108
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 13 13
Discomfort 8 8
Hematoma 7 7
Foreign Body Reaction 6 6
Insufficient Information 6 6
Fall 4 4
Fluid Discharge 4 4
Post Operative Wound Infection 3 3
Injury 3 3
Unspecified Tissue Injury 3 3
Arthritis 3 3
Hypersensitivity/Allergic reaction 2 2
Bone Fracture(s) 2 2
Pocket Erosion 2 2
Wound Dehiscence 1 1
Stroke/CVA 1 1
Arthralgia 1 1
Failure of Implant 1 1
Metal Related Pathology 1 1
Test Result 1 1
Adhesion(s) 1 1
Muscle Weakness 1 1
Cardiac Arrest 1 1
Seroma 1 1
Thrombosis/Thrombus 1 1
Thrombosis 1 1
Pneumonia 1 1
Heart Failure/Congestive Heart Failure 1 1
Embolism 1 1
Phlebitis 1 1
Tissue Damage 1 1
Erosion 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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