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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
2018 39 39
2020 2 2
2022 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 11 11
Insufficient Information 10 10
Device Dislodged or Dislocated 8 8
Fracture 5 5
Appropriate Term/Code Not Available 4 4
Loose or Intermittent Connection 3 3
Migration or Expulsion of Device 2 2
Unstable 2 2
Loss of Osseointegration 2 2
Mechanical Jam 2 2
Naturally Worn 2 2
Separation Failure 1 1
Loss of or Failure to Bond 1 1
Break 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 9 9
Pain 8 8
Joint Dislocation 8 8
Unspecified Infection 7 7
Not Applicable 5 5
Bone Fracture(s) 4 4
No Code Available 4 4
Insufficient Information 4 4
Fall 3 3
Loss of Range of Motion 3 3
No Consequences Or Impact To Patient 3 3
Inadequate Osseointegration 2 2
Tissue Damage 2 2
Tingling 1 1
Death 1 1
Muscular Rigidity 1 1
Limited Mobility Of The Implanted Joint 1 1
Joint Disorder 1 1
Ambulation Difficulties 1 1
Blood Loss 1 1
No Patient Involvement 1 1
No Clinical Signs, Symptoms or Conditions 1 1

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