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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
Product CodeJDK
Regulation Number 878.3300
Device Class 2


Premarket Reviews
ManufacturerDecision
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 13 13
2020 4 4
2021 3 3
2022 4 4
2023 7 7
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 15 15
Fracture 9 9
Break 7 7
Entrapment of Device 2 2
Difficult to Remove 2 2
Material Twisted/Bent 2 2
Material Deformation 2 2
Connection Problem 2 2
Device-Device Incompatibility 1 1
Mechanical Problem 1 1
Migration 1 1
Detachment of Device or Device Component 1 1
Naturally Worn 1 1
Loss of or Failure to Bond 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 9 9
Unspecified Infection 8 8
No Clinical Signs, Symptoms or Conditions 7 7
Pain 6 6
No Code Available 5 5
Not Applicable 2 2
Obstruction/Occlusion 2 2
Foreign Body In Patient 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Osteolysis 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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