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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device finger semi-constrained pyrolytic carbon uncemented prosthesis
Definition Pma approved: P000057
Product CodeNEG
Device Class 3

Premarket Approvals (PMA)
2016 2017 2018 2019 2020 2021
0 1 2 1 0 0

MDR Year MDR Reports MDR Events
2016 5 5
2017 4 4
2018 11 11
2019 12 12
2020 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 20 20
Fracture 3 3
Noise, Audible 3 3
Device Operates Differently Than Expected 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Positioning Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Malposition of Device 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1
Device Dislodged or Dislocated 1 1
Naturally Worn 1 1
Therapeutic or Diagnostic Output Failure 1 1
Appropriate Term/Code Not Available 1 1
Material Separation 1 1
Use of Device Problem 1 1
Burst Container or Vessel 1 1
Crack 1 1
Loosening of Implant Not Related to Bone-Ingrowth 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 15 15
Injury 13 13
No Code Available 4 4
Pain 3 3
No Consequences Or Impact To Patient 3 3
Bone Fracture(s) 2 2
No Information 2 2
Unspecified Infection 1 1
Discomfort 1 1

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