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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, knee, femorotibial, semi-constrained, cemented, trunnion-bearing
Product CodeLGE
Regulation Number 888.3530
Device Class 2

MDR Year MDR Reports MDR Events
2014 5 5
2015 2 2
2018 2 2
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 3 3
Loose or Intermittent Connection 2 2
Break 2 2
Insufficient Information 2 2
Inadequacy of Device Shape and/or Size 1 1
Fitting Problem 1 1
Device Operates Differently Than Expected 1 1
Device-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 4 4
Injury 2 2
No Known Impact Or Consequence To Patient 2 2
Fall 1 1
Bone Fracture(s) 1 1
Unspecified Infection 1 1
Insufficient Information 1 1

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