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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 57 57

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 97 102
Loosening of Implant Not Related to Bone-Ingrowth 38 38
Device Dislodged or Dislocated 17 35
Osseointegration Problem 15 23
Unstable 14 23
Insufficient Information 13 13
Fracture 11 11
Loss of Osseointegration 7 7
Patient Device Interaction Problem 6 6
Naturally Worn 6 6
Break 6 6
Appropriate Term/Code Not Available 6 6
Use of Device Problem 4 4
Detachment of Device or Device Component 4 4
Unintended Movement 3 3
Migration 3 3
Loss of or Failure to Bond 3 3
Inaccurate Information 2 2
Malposition of Device 2 2
Migration or Expulsion of Device 2 2
Device Slipped 1 1
Material Erosion 1 1
Therapeutic or Diagnostic Output Failure 1 1
Material Integrity Problem 1 1
Degraded 1 1
Improper or Incorrect Procedure or Method 1 1
Mechanical Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 43 47
Implant Pain 30 30
Insufficient Information 27 45
Failure of Implant 26 26
Joint Laxity 22 31
Loss of Range of Motion 22 22
Pain 20 20
Inadequate Osseointegration 16 24
No Information 15 15
Bone Fracture(s) 12 12
No Code Available 9 9
Swelling/ Edema 9 9
No Clinical Signs, Symptoms or Conditions 8 8
Discomfort 8 8
Joint Dislocation 7 7
Injury 7 7
Bacterial Infection 4 4
No Known Impact Or Consequence To Patient 4 4
Ossification 4 4
Fluid Discharge 4 4
Post Operative Wound Infection 4 4
Tissue Damage 3 3
Skin Inflammation/ Irritation 3 3
Inflammation 3 3
Osteolysis 3 3
No Consequences Or Impact To Patient 2 2
Limb Fracture 2 2
Reaction 2 2
Foreign Body In Patient 2 2
Post Traumatic Wound Infection 2 2
Cyst(s) 2 2
Neuropathy 2 2
Scar Tissue 1 1
Fall 1 1
Foreign Body Reaction 1 1
Adhesion(s) 1 1
Rheumatoid Arthritis 1 1
Unspecified Tissue Injury 1 1
Wound Dehiscence 1 1
Impaired Healing 1 1
Erosion 1 1
Device Embedded In Tissue or Plaque 1 1

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