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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 2

MDR Year MDR Reports MDR Events
2018 39 39
2019 30 30
2020 32 32
2021 27 27
2022 59 82
2023 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 59 64
Loosening of Implant Not Related to Bone-Ingrowth 32 32
Insufficient Information 30 30
Fracture 14 14
Device Dislodged or Dislocated 14 32
Appropriate Term/Code Not Available 8 8
Migration 8 8
Naturally Worn 7 7
Loss of Osseointegration 6 6
Break 6 6
Migration or Expulsion of Device 5 5
Detachment of Device or Device Component 4 4
Loss of or Failure to Bond 4 4
Unintended Movement 3 3
Patient Device Interaction Problem 2 2
Disassembly 2 2
Material Erosion 1 1
Degraded 1 1
Difficult to Insert 1 1
Loose or Intermittent Connection 1 1
Mechanical Problem 1 1
Material Integrity Problem 1 1
Misassembled 1 1
Device Slipped 1 1
Unstable 1 1
Inaccurate Information 1 1
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure of Implant 30 30
Unspecified Infection 29 33
Pain 28 28
No Information 24 24
Insufficient Information 21 39
No Code Available 15 15
Bone Fracture(s) 12 12
Loss of Range of Motion 12 12
Implant Pain 9 9
Injury 7 7
Joint Laxity 6 7
No Known Impact Or Consequence To Patient 6 6
No Clinical Signs, Symptoms or Conditions 6 6
Tissue Damage 5 5
Swelling/ Edema 5 5
Bacterial Infection 4 4
Fluid Discharge 4 4
Discomfort 4 4
Post Operative Wound Infection 4 4
Ossification 3 3
Sepsis 3 3
Death 3 3
Neuropathy 3 3
Wound Dehiscence 2 2
Numbness 2 2
Tingling 2 2
Patient Problem/Medical Problem 2 2
Foreign Body In Patient 2 2
No Consequences Or Impact To Patient 2 2
Joint Dislocation 2 2
Rheumatoid Arthritis 2 2
Impaired Healing 2 2
Reaction 2 2
Limb Fracture 2 2
Adhesion(s) 1 1
Scar Tissue 1 1
Foreign Body Reaction 1 1
Unspecified Tissue Injury 1 1
Erosion 1 1
Fall 1 1
Osteolysis 1 1
Fracture, Arm 1 1
Device Embedded In Tissue or Plaque 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Howmedica Osteonics Corp. II Aug-08-2018
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