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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cement obturator
Product CodeLZN
Regulation Number 878.3300
Device Class 2


Premarket Reviews
ManufacturerDecision
HOWMEDICA OSTEONICS, DBA STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 11 11
2020 11 11
2021 12 12
2022 6 6
2023 13 13
2024 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 25 25
Patient Device Interaction Problem 13 13
Adverse Event Without Identified Device or Use Problem 8 8
Break 5 5
Fracture 4 4
Delivered as Unsterile Product 4 4
Entrapment of Device 3 3
Leak/Splash 3 3
Insufficient Information 2 2
Device Handling Problem 1 1
Migration 1 1
Difficult to Remove 1 1
Shipping Damage or Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Tear, Rip or Hole in Device Packaging 1 1
Material Fragmentation 1 1
Crack 1 1
Degraded 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Osteolysis 27 27
No Clinical Signs, Symptoms or Conditions 10 10
Unspecified Infection 4 4
Failure of Implant 4 4
Device Embedded In Tissue or Plaque 4 4
Pain 3 3
No Code Available 2 2
Bone Fracture(s) 2 2
Implant Pain 2 2
Insufficient Information 2 2
Swelling/ Edema 2 2
No Consequences Or Impact To Patient 2 2
Inflammation 1 1
Cardiac Arrest 1 1
Foreign Body In Patient 1 1
Bacterial Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Depuy Ireland UC II Jan-12-2023
2 Stryker Corporation II Sep-19-2023
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