• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device prosthesis, elbow, semi-constrained, cemented
Regulation Description Elbow joint metal/polymer semi-constrained cemented prosthesis.
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
2020 32 32
2021 23 23
2022 58 81
2023 30 30
2024 163 163
2025 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 127 132
Osseointegration Problem 58 66
Unstable 33 42
Loosening of Implant Not Related to Bone-Ingrowth 31 31
Fracture 21 21
Device Dislodged or Dislocated 20 38
Break 17 17
Loss of Osseointegration 12 12
Patient Device Interaction Problem 9 9
Insufficient Information 7 7
Naturally Worn 5 5
Migration 4 4
Use of Device Problem 4 4
Detachment of Device or Device Component 4 4
Unintended Movement 3 3
Appropriate Term/Code Not Available 3 3
Inaccurate Information 2 2
Malposition of Device 2 2
Material Integrity Problem 1 1
Mechanical Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Material Erosion 1 1
Degraded 1 1
Loss of or Failure to Bond 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 65 69
Inadequate Osseointegration 59 67
Joint Laxity 46 55
Bone Fracture(s) 37 37
Failure of Implant 34 34
Implant Pain 33 33
Insufficient Information 27 45
Loss of Range of Motion 20 20
Pain 13 13
Osteolysis 10 10
Joint Dislocation 10 10
No Clinical Signs, Symptoms or Conditions 9 9
Swelling/ Edema 9 9
Discomfort 9 9
Injury 7 7
No Information 6 6
Fall 5 5
Fluid Discharge 4 4
Post Operative Wound Infection 4 4
Inadequate Pain Relief 4 4
Bacterial Infection 4 4
Skin Inflammation/ Irritation 3 3
Inflammation 3 3
Fever 3 3
Ossification 3 3
Sepsis 3 3
Cyst(s) 2 2
Reaction 2 2
Post Traumatic Wound Infection 2 2
Limb Fracture 2 2
Foreign Body In Patient 2 2
Neuropathy 2 2
Foreign Body Reaction 1 1
Erosion 1 1
Rheumatoid Arthritis 1 1
Adhesion(s) 1 1
Impaired Healing 1 1
Wound Dehiscence 1 1
No Code Available 1 1
Device Embedded In Tissue or Plaque 1 1
Unspecified Tissue Injury 1 1
Tissue Damage 1 1
Scar Tissue 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Limacorporate S.p.A II Dec-20-2024
-
-