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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
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 52 52

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 357 357
Insufficient Information 251 251
Device Dislodged or Dislocated 102 102
Appropriate Term/Code Not Available 13 13
Naturally Worn 13 13
Break 4 4
Device Contaminated During Manufacture or Shipping 3 3
Inadequacy of Device Shape and/or Size 3 3
Migration 3 3
Degraded 2 2
Difficult to Insert 2 2
Material Deformation 2 2
Disassembly 1 1
Material Twisted/Bent 1 1
No Apparent Adverse Event 1 1
Fracture 1 1
Nonstandard Device 1 1
Corroded 1 1
Improper or Incorrect Procedure or Method 1 1
Loss of or Failure to Bond 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 307 307
Pain 234 234
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 15 15
Discomfort 13 13
No Clinical Signs, Symptoms or Conditions 12 12
Hematoma 9 9
Fall 8 8
Foreign Body Reaction 6 6
Insufficient Information 6 6
Injury 5 5
Fluid Discharge 4 4
Osteolysis 4 4
Unspecified Tissue Injury 3 3
Host-Tissue Reaction 3 3
Post Operative Wound Infection 3 3
Hypersensitivity/Allergic reaction 2 2
Ambulation Difficulties 2 2
Pocket Erosion 2 2
No Consequences Or Impact To Patient 2 2
Failure of Implant 2 2
Erosion 2 2
Bone Fracture(s) 2 2
Tissue Damage 2 2
No Known Impact Or Consequence To Patient 2 2
Loss of Range of Motion 2 2
Hemorrhage/Bleeding 1 1
Phlebitis 1 1
Embolism 1 1
Heart Failure/Congestive Heart Failure 1 1
Pneumonia 1 1
Thrombosis 1 1
Swelling 1 1
Thrombosis/Thrombus 1 1
Seroma 1 1
Cardiac Arrest 1 1
Ossification 1 1
Edema 1 1
Muscle Weakness 1 1
Inflammation 1 1
Adhesion(s) 1 1
Test Result 1 1
Metal Related Pathology 1 1
Joint Disorder 1 1
Arthralgia 1 1
Hip Fracture 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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