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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device finger semi-constrained pyrolytic carbon uncemented prosthesis
Definition Pma approved: P000057
Product CodeNEG
Device Class 3

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

MDR Year MDR Reports MDR Events
2014 10 10
2015 10 10
2016 5 5
2017 4 4
2018 11 11
2019 12 12
2020 2 2
2021 4 4
2022 1 1
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 34 34
Fracture 11 11
Device Operates Differently Than Expected 5 5
Material Integrity Problem 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Noise, Audible 3 3
Insufficient Information 2 2
Device Slipped 2 2
Material Separation 2 2
Inadequacy of Device Shape and/or Size 1 1
Difficult to Remove 1 1
Burst Container or Vessel 1 1
Detachment Of Device Component 1 1
Crack 1 1
Use of Device Problem 1 1
Fitting Problem 1 1
Malposition of Device 1 1
Naturally Worn 1 1
Device Dislodged or Dislocated 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Appropriate Term/Code Not Available 1 1
Positioning Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Migration 1 1
Material Split, Cut or Torn 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 23 23
Injury 13 13
No Consequences Or Impact To Patient 12 12
Failure of Implant 6 6
Pain 6 6
No Code Available 5 5
Swelling 3 3
Synovitis 3 3
Numbness 3 3
Bone Fracture(s) 2 2
No Information 2 2
Test Result 1 1
Insufficient Information 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Therapeutic Response, Decreased 1 1
Discomfort 1 1
Unspecified Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ascension Orthopedics, Inc II May-04-2010
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