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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device prosthesis, shoulder, humeral (bipolar hemi-shoulder) metal/polymer, cemented or uncemented
Product CodeMJT
Device Class 3

MDR Year MDR Reports MDR Events
2016 11 11
2017 26 26
2018 39 39
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 29 29
Device Dislodged or Dislocated 11 11
Adverse Event Without Identified Device or Use Problem 8 8
Migration or Expulsion of Device 7 7
Fracture 6 6
Appropriate Term/Code Not Available 4 4
Loose or Intermittent Connection 4 4
Unstable 3 3
Loss of Osseointegration 2 2
Inadequacy of Device Shape and/or Size 2 2
Mechanical Jam 2 2
Naturally Worn 2 2
Loss of or Failure to Bond 2 2
Break 1 1
Difficult to Remove 1 1
Separation Failure 1 1
Defective Device 1 1
Patient-Device Incompatibility 1 1
Device Operates Differently Than Expected 1 1
Malposition of Device 1 1
Unintended System Motion 1 1
Material Erosion 1 1
Difficult to Insert 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 23 23
Pain 15 15
Joint Dislocation 11 11
No Code Available 9 9
Bone Fracture(s) 7 7
Unspecified Infection 6 6
Death 5 5
Not Applicable 5 5
Tissue Damage 4 4
Loss of Range of Motion 4 4
No Consequences Or Impact To Patient 3 3
Fall 2 2
Inadequate Osseointegration 2 2
Nerve Damage 2 2
Tingling 1 1
Joint Disorder 1 1
Blood Loss 1 1
No Patient Involvement 1 1
Damage to Ligament(s) 1 1
Muscular Rigidity 1 1
Hematoma 1 1
Inflammation 1 1
Ambulation Difficulties 1 1
Arthritis 1 1

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