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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device shoulder joint humeral (hemi-shoulder) ceramic head/metallic stem cemented or uncemented prosthesis
Definition A shoulder joint humeral (hemi-shoulder) ceramic head / metallic stem cemented or uncemented prosthesis is a device using a replacement humeral head made of ceramic materials, such as pyrolytic carbon,and a stem made of alloys, such as cobalt-chromium-molybdenum. It is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed with or without bone cement (§ 888.3027). This device is not intended for use in total shoulder arthroplasty.
Product CodeQKW
Regulation Number 888.3695
Device Class 2


Premarket Reviews
ManufacturerDecision
TORNIER SAS
  GRANTED 1

MDR Year MDR Reports MDR Events
2023 11 11
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4 4
Device Dislodged or Dislocated 2 2
Migration 2 2
Naturally Worn 1 1
Osseointegration Problem 1 1
Break 1 1
Material Erosion 1 1
Fracture 1 1
Device Damaged by Another Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Loss of Range of Motion 3 3
Implant Pain 3 3
Insufficient Information 2 2
Joint Dislocation 2 2
Osteolysis 1 1
Failure of Implant 1 1
Unspecified Infection 1 1
No Clinical Signs, Symptoms or Conditions 1 1

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