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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
MEDACTA INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 46 46
2015 97 97
2016 76 76
2017 72 72
2018 67 67
2019 59 59
2020 79 79
2021 59 59
2022 65 65
2023 77 77
2024 26 26

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 334 334
Insufficient Information 251 251
Device Dislodged or Dislocated 102 102
Appropriate Term/Code Not Available 13 13
Naturally Worn 10 10
Break 4 4
Device Contaminated During Manufacture or Shipping 3 3
Inadequacy of Device Shape and/or Size 3 3
Migration 3 3
Material Deformation 2 2
Difficult to Insert 2 2
Nonstandard Device 1 1
Improper or Incorrect Procedure or Method 1 1
Corroded 1 1
Fracture 1 1
Material Twisted/Bent 1 1
Loss of or Failure to Bond 1 1
Disassembly 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 293 293
Pain 226 226
No Code Available 150 150
Joint Dislocation 67 67
No Information 49 50
Not Applicable 23 23
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 21 21
Joint Laxity 13 13
Discomfort 13 13
No Clinical Signs, Symptoms or Conditions 12 12
Hematoma 9 9
Fall 8 8
Foreign Body Reaction 6 6
Injury 5 5
Osteolysis 4 4
Fluid Discharge 4 4
Insufficient Information 4 4
Unspecified Tissue Injury 3 3
Post Operative Wound Infection 3 3
Host-Tissue Reaction 3 3
Bone Fracture(s) 2 2
Erosion 2 2
Hypersensitivity/Allergic reaction 2 2
Failure of Implant 2 2
Ambulation Difficulties 2 2
No Known Impact Or Consequence To Patient 2 2
Tissue Damage 2 2
No Consequences Or Impact To Patient 2 2
Pocket Erosion 2 2
Loss of Range of Motion 2 2
Seroma 1 1
Swelling 1 1
Thrombosis 1 1
Hip Fracture 1 1
Arthralgia 1 1
Joint Disorder 1 1
Test Result 1 1
Hemorrhage/Bleeding 1 1
Phlebitis 1 1
Pneumonia 1 1
Inflammation 1 1
Muscle Weakness 1 1
Cardiac Arrest 1 1
Stroke/CVA 1 1
Edema 1 1
Embolism 1 1
Ossification 1 1
Adhesion(s) 1 1
Metal Related Pathology 1 1
Wound Dehiscence 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
2 Smith & Nephew Inc II Sep-24-2009
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