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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-, tibial, resurfacing (uncemented)
Product CodeHSH
Regulation Number 888.3590
Device Class 2

MDR Year MDR Reports MDR Events
2014 14 14
2015 16 16
2017 3 3
2018 3 3
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 14 14
Adverse Event Without Identified Device or Use Problem 4 4
Loose or Intermittent Connection 3 3
Loss of or Failure to Bond 3 3
Detachment Of Device Component 3 3
Break 2 2
Device Slipped 2 2
Appropriate Term/Code Not Available 2 2
Failure To Adhere Or Bond 2 2
Noise, Audible 1 1
Migration or Expulsion of Device 1 1
Therapeutic or Diagnostic Output Failure 1 1
Device Dislodged or Dislocated 1 1
Material Integrity Problem 1 1
Naturally Worn 1 1
Crack 1 1
Fracture 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 11 11
Pain 8 8
No Known Impact Or Consequence To Patient 4 4
No Information 4 4
Unspecified Infection 3 3
Fall 2 2
Wound Dehiscence 1 1
Sepsis 1 1
No Consequences Or Impact To Patient 1 1
Complaint, Ill-Defined 1 1
Injury 1 1
Ambulation Difficulties 1 1
No Clinical Signs, Symptoms or Conditions 1 1

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