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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, knee, patello/femorotibial, constrained, cemented, polymer/metal/metal
Regulation Description Knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis.
Definition Call for PMAs to be filed by 12/26/96 per 61 FR 50710 on 9/27/96
Product CodeKRP
Regulation Number 888.3550
Device Class 3

MDR Year MDR Reports MDR Events
2017 2 2
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 3 3
Material Deformation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 2 2
No Information 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Foreign Body Reaction 1 1

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