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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented
Regulation Description Shoulder joint metal/polymer semi-constrained cemented prosthesis.
Definition Total shoulders are indicated for arthritis (osteo-, rheumatoid, traumatic), avascular necrosis, correction of functional deformity, and revision procedures.
Product CodePAO
Regulation Number 888.3660
Device Class 2

MDR Year MDR Reports MDR Events
2021 7 7
2022 9 9
2023 64 64
2024 85 85
2025 88 88
2026 21 21

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 214 214
Unstable 29 29
Device Dislodged or Dislocated 20 20
Mechanical Problem 6 6
Detachment of Device or Device Component 5 5
Osseointegration Problem 5 5
Patient Device Interaction Problem 4 4
No Apparent Adverse Event 4 4
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Positioning Failure 2 2
Inadequacy of Device Shape and/or Size 2 2
Migration 2 2
Fracture 2 2
Appropriate Term/Code Not Available 2 2
Separation Problem 1 1
Break 1 1
Migration or Expulsion of Device 1 1
Off-Label Use 1 1
Unintended Movement 1 1
Difficult to Insert 1 1
Device Difficult to Setup or Prepare 1 1
Difficult or Delayed Positioning 1 1
Unintended System Motion 1 1
Naturally Worn 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Joint Laxity 69 69
Implant Pain 47 47
Unspecified Infection 34 34
Joint Dislocation 31 31
Insufficient Information 30 30
Loss of Range of Motion 18 18
Bone Fracture(s) 16 16
Pain 16 16
Failure of Implant 14 14
No Clinical Signs, Symptoms or Conditions 11 11
Foreign Body In Patient 6 6
Limb Fracture 6 6
Subluxation 5 5
Fall 4 4
Metal Related Pathology 3 3
Inadequate Osseointegration 3 3
Fever 3 3
Numbness 3 3
Arthralgia 2 2
Post Operative Wound Infection 2 2
Discomfort 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Sepsis 1 1
Dizziness 1 1
Inflammation 1 1
Hematoma 1 1
Embolism/Embolus 1 1
Confusion/ Disorientation 1 1
Paralysis 1 1
Thrombosis/Thrombus 1 1
Hyperextension 1 1
Abscess 1 1
Muscle/Tendon Damage 1 1
Malunion of Bone 1 1
Fluid Discharge 1 1
Non-union Bone Fracture 1 1
Urinary Frequency 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Tornier, Inc II Sep-27-2024
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