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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
Product CodeHSA
Regulation Number 888.3570
Device Class 3

MDR Year MDR Reports MDR Events
2014 12 12
2015 10 10
2016 1 1
2017 3 3
2022 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Failure To Adhere Or Bond 5 5
Break 5 5
Insufficient Information 4 4
Patient Device Interaction Problem 3 3
Loose or Intermittent Connection 3 3
Loss of Osseointegration 2 2
Device Operates Differently Than Expected 2 2
Device Slipped 2 2
Unstable 1 1
Appropriate Term/Code Not Available 1 1
Device Dislodged or Dislocated 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Naturally Worn 1 1
Material Separation 1 1
Disassembly 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 7 7
Pain 6 6
No Code Available 5 5
No Known Impact Or Consequence To Patient 5 5
Bone Fracture(s) 3 3
Foreign Body Reaction 2 2
Unspecified Infection 2 2
Joint Laxity 1 1
Fall 1 1
Failure of Implant 1 1
Disability 1 1
Joint Dislocation 1 1
Osteolysis 1 1
Ambulation Difficulties 1 1
Limited Mobility Of The Implanted Joint 1 1

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