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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


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 68 68

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 340 340
Device Dislodged or Dislocated 41 41
Naturally Worn 9 9
Device Contaminated During Manufacture or Shipping 3 3
Migration 3 3
Break 2 2
Degraded 2 2
Difficult to Insert 2 2
Material Deformation 2 2
Inadequacy of Device Shape and/or Size 2 2
Fracture 2 2
Off-Label Use 1 1
Insufficient Information 1 1
Material Twisted/Bent 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 169 169
No Code Available 129 129
Pain 113 113
Joint Dislocation 49 49
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
Unspecified Tissue Injury 3 3
Injury 3 3
Post Operative Wound Infection 3 3
Arthritis 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
Arthralgia 1 1
Metal Related Pathology 1 1
Test Result 1 1
Thrombosis/Thrombus 1 1
Heart Failure/Congestive Heart Failure 1 1
Failure of Implant 1 1
Hemorrhage/Bleeding 1 1
Phlebitis 1 1
Pneumonia 1 1
Muscle Weakness 1 1
Wound Dehiscence 1 1
Adhesion(s) 1 1
Erosion 1 1
Cardiac Arrest 1 1
Stroke/CVA 1 1
Embolism 1 1

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