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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
2019 17 17
2020 7 7
2021 7 7
2022 9 9
2023 65 65
2024 85 85
2025 39 39

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 176 176
Unstable 22 22
Device Dislodged or Dislocated 19 19
Appropriate Term/Code Not Available 6 6
Insufficient Information 4 4
Detachment of Device or Device Component 4 4
No Apparent Adverse Event 4 4
Loosening of Implant Not Related to Bone-Ingrowth 3 3
Difficult to Insert 3 3
Osseointegration Problem 3 3
Positioning Failure 2 2
Difficult or Delayed Positioning 2 2
Migration 2 2
Material Split, Cut or Torn 1 1
Separation Problem 1 1
Break 1 1
Migration or Expulsion of Device 1 1
Patient Device Interaction Problem 1 1
Device Difficult to Setup or Prepare 1 1
Inadequacy of Device Shape and/or Size 1 1
Fracture 1 1
Naturally Worn 1 1
Loose or Intermittent Connection 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Joint Laxity 51 51
Implant Pain 46 46
Joint Dislocation 28 28
Unspecified Infection 24 24
Insufficient Information 24 24
Loss of Range of Motion 18 18
Pain 13 13
Failure of Implant 12 12
Bone Fracture(s) 12 12
Limb Fracture 6 6
Subluxation 5 5
No Clinical Signs, Symptoms or Conditions 4 4
Foreign Body In Patient 4 4
No Known Impact Or Consequence To Patient 3 3
Fever 3 3
Numbness 3 3
Fall 3 3
Arthralgia 2 2
Inadequate Osseointegration 2 2
No Code Available 2 2
Metal Related Pathology 2 2
No Information 2 2
Hematoma 2 2
Inflammation 2 2
Discomfort 2 2
Muscle/Tendon Damage 2 2
No Consequences Or Impact To Patient 2 2
Fracture, Arm 1 1
Patient Problem/Medical Problem 1 1
Sepsis 1 1
Dizziness 1 1
Embolism/Embolus 1 1
Confusion/ Disorientation 1 1
Paralysis 1 1
Thrombosis/Thrombus 1 1
Swelling 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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