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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 75 75

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 130 130
Device Dislodged or Dislocated 19 19
Unstable 18 18
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
Positioning Failure 2 2
Migration 2 2
Osseointegration Problem 2 2
Material Split, Cut or Torn 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
Difficult or Delayed Positioning 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 43 43
Implant Pain 28 28
Joint Dislocation 24 24
Unspecified Infection 18 18
Insufficient Information 18 18
Loss of Range of Motion 13 13
Failure of Implant 11 11
Pain 11 11
Bone Fracture(s) 6 6
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
Fall 3 3
Arthralgia 2 2
No Code Available 2 2
Metal Related Pathology 2 2
No Information 2 2
Inflammation 2 2
Fever 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
Inadequate Osseointegration 1 1
Dizziness 1 1
Hematoma 1 1
Confusion/ Disorientation 1 1
Paralysis 1 1
Swelling 1 1
Numbness 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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