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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 65 65
2024 85 85
2025 25 25

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 162 162
Unstable 19 19
Device Dislodged or Dislocated 15 15
Detachment of Device or Device Component 4 4
No Apparent Adverse Event 4 4
Osseointegration Problem 3 3
Positioning Failure 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
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
Inadequacy of Device Shape and/or Size 1 1
Naturally Worn 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Joint Laxity 47 47
Implant Pain 41 41
Joint Dislocation 25 25
Insufficient Information 23 23
Unspecified Infection 21 21
Loss of Range of Motion 18 18
Failure of Implant 12 12
Bone Fracture(s) 10 10
Pain 10 10
Limb Fracture 6 6
Subluxation 5 5
No Clinical Signs, Symptoms or Conditions 4 4
Foreign Body In Patient 4 4
Fever 3 3
Numbness 3 3
Fall 3 3
Arthralgia 2 2
Inadequate Osseointegration 2 2
Metal Related Pathology 2 2
Discomfort 2 2
Muscle/Tendon Damage 2 2
Patient Problem/Medical Problem 1 1
Sepsis 1 1
Dizziness 1 1
Hematoma 1 1
Inflammation 1 1
Embolism/Embolus 1 1
Confusion/ Disorientation 1 1
Paralysis 1 1
Thrombosis/Thrombus 1 1
Hyperextension 1 1
Abscess 1 1
Malunion of Bone 1 1
Urinary Frequency 1 1

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