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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 S.A.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 3 3
2022 4 4
2023 7 7
2024 5 5
2025 6 13

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 10 10
Fracture 9 16
Break 3 3
Detachment of Device or Device Component 2 2
Mechanical Problem 1 1
Naturally Worn 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 11 18
Unspecified Infection 6 6
Insufficient Information 3 10
Obstruction/Occlusion 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Pain 1 1
Joint Laxity 1 1
Unspecified Tissue Injury 1 1
Pocket Erosion 1 1

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