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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


Premarket Reviews
ManufacturerDecision
TORNIER, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 7 7
2021 7 7
2022 9 9
2023 64 64
2024 85 85
2025 83 83

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 206 206
Unstable 24 24
Device Dislodged or Dislocated 21 21
Detachment of Device or Device Component 6 6
Osseointegration Problem 5 5
No Apparent Adverse Event 4 4
Mechanical Problem 2 2
Positioning Failure 2 2
Inadequacy of Device Shape and/or Size 2 2
Migration 2 2
Appropriate Term/Code Not Available 2 2
Separation Problem 1 1
Break 1 1
Migration or Expulsion of Device 1 1
Unintended Movement 1 1
Insufficient Information 1 1
Patient Device Interaction Problem 1 1
Difficult to Insert 1 1
Device Difficult to Setup or Prepare 1 1
Difficult or Delayed Positioning 1 1
Fracture 1 1
Naturally Worn 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Joint Laxity 60 60
Implant Pain 47 47
Joint Dislocation 35 35
Unspecified Infection 31 31
Insufficient Information 27 27
Loss of Range of Motion 19 19
Pain 16 16
Bone Fracture(s) 15 15
Failure of Implant 13 13
No Clinical Signs, Symptoms or Conditions 6 6
Limb Fracture 6 6
Foreign Body In Patient 5 5
Subluxation 5 5
Fall 4 4
Inadequate Osseointegration 3 3
Metal Related Pathology 3 3
Fever 3 3
Numbness 3 3
Arthralgia 2 2
Discomfort 2 2
Muscle/Tendon Damage 2 2
Patient Problem/Medical Problem 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Sepsis 1 1
Dizziness 1 1
Hematoma 1 1
Inflammation 1 1
Embolism/Embolus 1 1
Post Operative Wound Infection 1 1
Confusion/ Disorientation 1 1
Paralysis 1 1
Thrombosis/Thrombus 1 1
Hyperextension 1 1
Abscess 1 1
Malunion of Bone 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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