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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
Inadequacy of Device Shape and/or Size 2 2
Loss of or Failure to Bond 2 2
Mechanical Jam 2 2
Naturally Worn 2 2
Loss of Osseointegration 2 2
Separation Failure 1 1
Defective Device 1 1
Malposition of Device 1 1
Patient-Device Incompatibility 1 1
Device Operates Differently Than Expected 1 1
Break 1 1
Material Erosion 1 1
Difficult to Insert 1 1
Unintended System Motion 1 1
Difficult to Remove 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
Loss of Range of Motion 5 5
Not Applicable 5 5
Insufficient Information 4 4
Tissue Damage 4 4
No Consequences Or Impact To Patient 3 3
Fall 3 3
Nerve Damage 2 2
Inadequate Osseointegration 2 2
Limited Mobility Of The Implanted Joint 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Ambulation Difficulties 1 1
Blood Loss 1 1
No Patient Involvement 1 1
Arthritis 1 1
Joint Disorder 1 1
Tingling 1 1
Hematoma 1 1
Inflammation 1 1
Damage to Ligament(s) 1 1
Muscular Rigidity 1 1

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