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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, hip, semi-constrained, ceramic-on-metal articulation
Definition Intended as a primary joint replacement prosthesis in total hip arthroplasty.
Product CodeOVO
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 2 6 1 0 0 0 0 0 0 0 0 0 0 0

MDR Year MDR Reports MDR Events
2016 1 1
2017 6 6
2018 8 8
2019 2 2
2020 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 9 9
Naturally Worn 3 3
Adverse Event Without Identified Device or Use Problem 2 2
Noise, Audible 2 2
Device Dislodged or Dislocated 2 2
Corroded 1 1
Material Disintegration 1 1
Fitting Problem 1 1
Loss of Osseointegration 1 1
Malposition of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 12 12
No Code Available 5 5
Test Result 3 3
Injury 2 2
Joint Dislocation 2 2
No Information 2 2
Insufficient Information 1 1
Ambulation Difficulties 1 1
Not Applicable 1 1
Loss of Range of Motion 1 1
Swelling 1 1
Tissue Damage 1 1
No Consequences Or Impact To Patient 1 1
Host-Tissue Reaction 1 1
Bone Fracture(s) 1 1
Unspecified Infection 1 1
Inflammation 1 1
Necrosis 1 1

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