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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
Regulation Description Elbow joint metal/polymer semi-constrained cemented prosthesis.
Product CodeJDB
Regulation Number 888.3160
Device Class 2


Premarket Reviews
ManufacturerDecision
TORNIER
  SUBSTANTIALLY EQUIVALENT 3
TORNIER INC.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2015 44 44
2016 11 11
2017 26 26
2018 39 39
2019 30 30
2020 27 27

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 43 43
Insufficient Information 41 41
Device Dislodged or Dislocated 18 18
Migration or Expulsion of Device 11 11
Mechanical Problem 10 10
Loosening of Implant Not Related to Bone-Ingrowth 9 9
Detachment of Device or Device Component 9 9
Naturally Worn 8 8
Disassembly 7 7
Fracture 7 7
Loss of Osseointegration 7 7
Appropriate Term/Code Not Available 6 6
Loss of or Failure to Bond 4 4
Loose or Intermittent Connection 4 4
Unstable 3 3
Migration 3 3
Improper or Incorrect Procedure or Method 2 2
Compatibility Problem 2 2
Break 2 2
Device Operates Differently Than Expected 2 2
Device Slipped 2 2
Packaging Problem 2 2
Protective Measures Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Missing Value Reason 1 1
Device Issue 1 1
Degraded 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1
Misassembled 1 1
Product Quality Problem 1 1
Wire 1 1
Material Erosion 1 1
Difficult to Insert 1 1
Fitting Problem 1 1
Positioning Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 40 40
No Information 36 36
No Code Available 32 32
Unspecified Infection 30 30
Failure of Implant 30 30
No Known Impact Or Consequence To Patient 18 18
Loss of Range of Motion 11 11
Bone Fracture(s) 8 8
Injury 7 7
Tissue Damage 5 5
Reaction 4 4
Death 4 4
Patient Problem/Medical Problem 4 4
Sepsis 3 3
Rheumatoid Arthritis 3 3
Rupture 3 3
Fracture, Arm 2 2
Joint Dislocation 2 2
Osteolysis 2 2
Inflammation 2 2
Neuropathy 2 2
Swelling 2 2
No Consequences Or Impact To Patient 2 2
Nerve Damage 2 2
Tingling 2 2
Discomfort 1 1
Burning Sensation 1 1
Post Operative Wound Infection 1 1
Impaired Healing 1 1
Undesired Nerve Stimulation 1 1
Necrosis 1 1
Foreign Body Reaction 1 1
Ossification 1 1
Bronchitis 1 1
Device Embedded In Tissue or Plaque 1 1
Hypersensitivity/Allergic reaction 1 1
Wound Dehiscence 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Howmedica Osteonics Corp. II Aug-08-2018
2 Stryker Howmedica Osteonics Corp. II Aug-20-2015
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