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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, elbow, semi-constrained, cemented
Product CodeJDB
Regulation Number 888.3160
Device Class 2


Premarket Reviews
ManufacturerDecision
LIMACORPORATE S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
TORNIER INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 30 30
2020 32 32
2021 23 23
2022 60 83
2023 30 30
2024 43 43

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 84 89
Loosening of Implant Not Related to Bone-Ingrowth 38 38
Device Dislodged or Dislocated 17 35
Osseointegration Problem 13 21
Unstable 13 22
Insufficient Information 13 13
Fracture 11 11
Loss of Osseointegration 7 7
Break 6 6
Appropriate Term/Code Not Available 6 6
Patient Device Interaction Problem 5 5
Naturally Worn 5 5
Use of Device Problem 4 4
Detachment of Device or Device Component 4 4
Loss of or Failure to Bond 3 3
Unintended Movement 3 3
Migration 3 3
Inaccurate Information 2 2
Malposition of Device 2 2
Migration or Expulsion of Device 2 2
Device Slipped 1 1
Improper or Incorrect Procedure or Method 1 1
Degraded 1 1
Material Erosion 1 1
Mechanical Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Material Integrity Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 33 37
Insufficient Information 27 45
Failure of Implant 25 25
Loss of Range of Motion 21 21
Joint Laxity 21 30
Implant Pain 20 20
Pain 20 20
No Information 15 15
Inadequate Osseointegration 14 22
No Code Available 9 9
Bone Fracture(s) 9 9
No Clinical Signs, Symptoms or Conditions 8 8
Discomfort 7 7
Injury 7 7
Joint Dislocation 7 7
Swelling/ Edema 6 6
No Known Impact Or Consequence To Patient 4 4
Fluid Discharge 4 4
Post Operative Wound Infection 4 4
Ossification 4 4
Bacterial Infection 4 4
Inflammation 3 3
Tissue Damage 3 3
Osteolysis 3 3
Post Traumatic Wound Infection 2 2
Foreign Body In Patient 2 2
Limb Fracture 2 2
No Consequences Or Impact To Patient 2 2
Neuropathy 2 2
Cyst(s) 2 2
Reaction 2 2
Fall 1 1
Foreign Body Reaction 1 1
Wound Dehiscence 1 1
Erosion 1 1
Adhesion(s) 1 1
Rheumatoid Arthritis 1 1
Scar Tissue 1 1
Device Embedded In Tissue or Plaque 1 1
Unspecified Tissue Injury 1 1
Impaired Healing 1 1

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