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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-, patellar resurfacing, uncemented
Product CodeHTG
Regulation Number 888.3580
Device Class 2

MDR Year MDR Reports MDR Events
2014 13 13
2015 4 4
2018 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 8 8
Loose or Intermittent Connection 5 5
Loss of or Failure to Bond 2 2
Naturally Worn 2 2
Noise, Audible 2 2
Protective Measures Problem 1 1
Material Disintegration 1 1
Fracture 1 1
Migration or Expulsion of Device 1 1
Shelf Life Exceeded 1 1
Patient-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 10 10
Osteolysis 6 6
No Known Impact Or Consequence To Patient 4 4
No Information 2 2
No Code Available 2 2
Joint Swelling 2 2
Depression 1 1
Ambulation Difficulties 1 1
Foreign Body In Patient 1 1
Loss of Range of Motion 1 1
Scarring 1 1
Increased Sensitivity 1 1
Toxicity 1 1
Test Result 1 1
Not Applicable 1 1
Hearing Loss 1 1

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