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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device u.v. method, cpk isoenzymes
Product CodeJHW
Regulation Number 862.1215
Device Class 2

MDR Year MDR Reports MDR Events
2021 1 1
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Naturally Worn 2 2
Patient-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Osteolysis 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Failure of Implant 1 1
Implant Pain 1 1
Synovitis 1 1
Pain 1 1
Joint Laxity 1 1
Ambulation Difficulties 1 1

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