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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 59 82
2023 30 30
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 67 72
Loosening of Implant Not Related to Bone-Ingrowth 38 38
Insufficient Information 13 13
Device Dislodged or Dislocated 12 30
Fracture 11 11
Loss of Osseointegration 7 7
Break 6 6
Naturally Worn 5 5
Appropriate Term/Code Not Available 5 5
Patient Device Interaction Problem 4 4
Detachment of Device or Device Component 4 4
Use of Device Problem 4 4
Loss of or Failure to Bond 3 3
Osseointegration Problem 3 3
Migration 3 3
Unintended Movement 3 3
Inaccurate Information 2 2
Migration or Expulsion of Device 2 2
Device Slipped 1 1
Unstable 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 26 30
Failure of Implant 25 25
Insufficient Information 23 41
Pain 20 20
Implant Pain 18 18
No Information 15 15
Loss of Range of Motion 14 14
Joint Laxity 10 11
No Code Available 9 9
Bone Fracture(s) 8 8
No Clinical Signs, Symptoms or Conditions 8 8
Injury 7 7
Swelling/ Edema 6 6
Bacterial Infection 4 4
Fluid Discharge 4 4
Discomfort 4 4
No Known Impact Or Consequence To Patient 4 4
Post Operative Wound Infection 4 4
Ossification 4 4
Inadequate Osseointegration 3 3
Tissue Damage 3 3
Inflammation 3 3
Foreign Body In Patient 2 2
Reaction 2 2
Limb Fracture 2 2
Joint Dislocation 2 2
No Consequences Or Impact To Patient 2 2
Post Traumatic Wound Infection 2 2
Neuropathy 2 2
Wound Dehiscence 1 1
Device Embedded In Tissue or Plaque 1 1
Osteolysis 1 1
Fall 1 1
Erosion 1 1
Rheumatoid Arthritis 1 1
Adhesion(s) 1 1
Scar Tissue 1 1
Impaired Healing 1 1
Unspecified Tissue Injury 1 1
Foreign Body Reaction 1 1

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