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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, hip, cement restrictor
Regulation Description Surgical mesh.
Product CodeJDK
Regulation Number 878.3300
Device Class 2


Premarket Reviews
ManufacturerDecision
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 4 4
2021 3 3
2022 4 4
2023 7 7
2024 6 6
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 10 10
Fracture 7 7
Break 5 5
Material Twisted/Bent 2 2
Detachment of Device or Device Component 2 2
Entrapment of Device 1 1
Mechanical Problem 1 1
Material Deformation 1 1
Naturally Worn 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 9 9
Unspecified Infection 6 6
Obstruction/Occlusion 2 2
Foreign Body In Patient 2 2
Pain 2 2
No Consequences Or Impact To Patient 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Code Available 1 1
Insufficient Information 1 1
Joint Laxity 1 1

Recalls
Manufacturer Recall Class Date Posted
1 MEDLINE INDUSTRIES, LP - Northfield II Mar-29-2024
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