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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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 2 2
2022 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 29 29
Adverse Event Without Identified Device or Use Problem 13 13
Device Dislodged or Dislocated 12 12
Migration or Expulsion of Device 7 7
Fracture 6 6
Unstable 5 5
Appropriate Term/Code Not Available 4 4
Loose or Intermittent Connection 4 4
Loss of Osseointegration 2 2
Loss of or Failure to Bond 2 2
Inadequacy of Device Shape and/or Size 2 2
Naturally Worn 2 2
Mechanical Jam 2 2
Device Operates Differently Than Expected 1 1
Break 1 1
Malposition of Device 1 1
Material Erosion 1 1
Patient-Device Incompatibility 1 1
Separation Failure 1 1
Unintended System Motion 1 1
Defective Device 1 1
Difficult to Remove 1 1
Difficult to Insert 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 23 23
Pain 17 17
Joint Dislocation 12 12
Unspecified Infection 10 10
No Code Available 9 9
Bone Fracture(s) 7 7
Death 5 5
Not Applicable 5 5
Loss of Range of Motion 5 5
Insufficient Information 4 4
Tissue Damage 4 4
Fall 3 3
No Consequences Or Impact To Patient 3 3
Inadequate Osseointegration 2 2
Nerve Damage 2 2
Damage to Ligament(s) 1 1
Tingling 1 1
Joint Disorder 1 1
Limited Mobility Of The Implanted Joint 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Hematoma 1 1
Inflammation 1 1
Blood Loss 1 1
Muscular Rigidity 1 1
No Patient Involvement 1 1
Arthritis 1 1
Ambulation Difficulties 1 1

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