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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
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 15 15

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 78 78
Device Dislodged or Dislocated 15 15
Unstable 10 10
Appropriate Term/Code Not Available 6 6
Insufficient Information 4 4
Detachment of Device or Device Component 4 4
Difficult to Insert 3 3
Loosening of Implant Not Related to Bone-Ingrowth 3 3
No Apparent Adverse Event 3 3
Material Split, Cut or Torn 1 1
Difficult or Delayed Positioning 1 1
Migration 1 1
Fracture 1 1
Migration or Expulsion of Device 1 1
Positioning Failure 1 1
Patient Device Interaction Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Loose or Intermittent Connection 1 1
Naturally Worn 1 1
Noise, Audible 1 1
Break 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Joint Laxity 23 23
Joint Dislocation 18 18
Implant Pain 17 17
Unspecified Infection 11 11
Failure of Implant 10 10
Loss of Range of Motion 10 10
Pain 9 9
Insufficient Information 9 9
Bone Fracture(s) 6 6
Limb Fracture 5 5
No Known Impact Or Consequence To Patient 3 3
Foreign Body In Patient 3 3
Fall 3 3
Inflammation 2 2
No Consequences Or Impact To Patient 2 2
No Information 2 2
No Code Available 2 2
Metal Related Pathology 2 2
Arthralgia 2 2
Muscle/Tendon Damage 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Subluxation 1 1
Patient Problem/Medical Problem 1 1
Numbness 1 1
Confusion/ Disorientation 1 1
Urinary Frequency 1 1
Discomfort 1 1
Fracture, Arm 1 1
Paralysis 1 1
Swelling 1 1
Dizziness 1 1
Abscess 1 1
Fever 1 1
Hematoma 1 1

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