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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
Device Slipped 2 2
Malposition of Device 2 2
Insufficient Information 2 2
Material Separation 2 2
Material Split, Cut or Torn 1 1
Fitting Problem 1 1
Burst Container or Vessel 1 1
Crack 1 1
Positioning Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Inadequacy of Device Shape and/or Size 1 1
Migration 1 1
Difficult to Remove 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Use of Device Problem 1 1
Device Dislodged or Dislocated 1 1
Appropriate Term/Code Not Available 1 1
Naturally Worn 1 1
Detachment Of Device Component 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
Synovitis 3 3
Swelling 3 3
Numbness 3 3
No Information 2 2
Bone Fracture(s) 2 2
Unspecified Infection 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Test Result 1 1
Discomfort 1 1
Insufficient Information 1 1
Therapeutic Response, Decreased 1 1

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