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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)
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
2014 3 3
2015 1 1
2016 1 1
2017 1 1
2019 2 2
2020 1 1
2022 2 2
2023 1 1
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 4 4
Adverse Event Without Identified Device or Use Problem 2 2
Break 2 2
Osseointegration Problem 1 1
Appropriate Term/Code Not Available 1 1
Loose or Intermittent Connection 1 1
Device Dislodged or Dislocated 1 1
Incorrect Device Or Component Shipped 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure of Implant 4 4
No Information 3 3
Pain 3 3
Loss of Range of Motion 1 1
Scar Tissue 1 1
Swelling 1 1
Joint Dislocation 1 1
Reaction 1 1
Ambulation Difficulties 1 1
No Known Impact Or Consequence To Patient 1 1
Unspecified Infection 1 1
Bone Fracture(s) 1 1
Hypersensitivity/Allergic reaction 1 1

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