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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, knee, hemi-, femoral (uncemented)
Product CodeKRS
Regulation Number 888.3570
Device Class 3

MDR Year MDR Reports MDR Events
2023 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Bone Fracture(s) 1 1
Failure of Implant 1 1
Insufficient Information 1 1

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