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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, knee, hinged (metal-metal)
Regulation Description Knee joint femorotibial metallic constrained cemented prosthesis.
Definition PMAs to be filed by 12/26/96 (61 FR 50710 (9/27/96))
Product CodeHRZ
Regulation Number 888.3480
Device Class 3

MDR Year MDR Reports MDR Events
2015 1 1
2016 1 1
2017 1 1
2019 2 2
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 2 2
Fracture 2 2
Incorrect Device Or Component Shipped 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Osseointegration Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure of Implant 2 2
No Information 2 2
Unspecified Infection 1 1
No Known Impact Or Consequence To Patient 1 1

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