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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, elbow, hemi-, humeral, metal
Definition call for pmas to be filed by 12/26/96 per 61 FR 50709 on 9/27/96
Product CodeKWJ
Regulation Number 888.3180
Device Class 3

MDR Year MDR Reports MDR Events
2016 1 1
2019 2 2
2020 1 1
2021 1 1
2022 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5 5
Insufficient Information 3 3
Naturally Worn 2 2
Fracture 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 4 4
No Information 2 2
Insufficient Information 2 2
Device Embedded In Tissue or Plaque 1 1
Failure of Implant 1 1

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