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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 28 28

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 89 89
Device Dislodged or Dislocated 15 15
Unstable 11 11
Appropriate Term/Code Not Available 6 6
No Apparent Adverse Event 4 4
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
Positioning Failure 2 2
Migration 2 2
Fracture 1 1
Migration or Expulsion of Device 1 1
Device Difficult to Setup or Prepare 1 1
Material Split, Cut or Torn 1 1
Difficult or Delayed Positioning 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 29 29
Joint Dislocation 19 19
Implant Pain 18 18
Unspecified Infection 12 12
Loss of Range of Motion 11 11
Insufficient Information 11 11
Failure of Implant 10 10
Pain 9 9
Bone Fracture(s) 6 6
Limb Fracture 6 6
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
No Clinical Signs, Symptoms or Conditions 2 2
Metal Related Pathology 2 2
Muscle/Tendon Damage 2 2
Arthralgia 2 2
Hyperextension 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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