• 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, constrained, cemented
Regulation Description Elbow joint metal/polymer constrained cemented prosthesis.
Product CodeJDC
Regulation Number 888.3150
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMET MANUFACTURING CORP.
  SUBSTANTIALLY EQUIVALENT 1
LIMACORPORATE S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 176 176
2017 401 401
2018 243 243
2019 189 189
2020 179 179
2021 121 121

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 352 352
Appropriate Term/Code Not Available 152 152
Adverse Event Without Identified Device or Use Problem 143 143
Loose or Intermittent Connection 120 120
Fracture 120 120
Migration or Expulsion of Device 118 118
Naturally Worn 80 80
Loosening of Implant Not Related to Bone-Ingrowth 60 60
Device Dislodged or Dislocated 39 39
Break 34 34
Failure To Adhere Or Bond 27 27
Unstable 25 25
Migration 24 24
Packaging Problem 19 19
Loss of or Failure to Bond 18 18
Device Markings/Labelling Problem 18 18
Malposition of Device 17 17
Device Slipped 17 17
Difficult to Insert 16 16
Detachment of Device or Device Component 13 13
Device Operates Differently Than Expected 9 9
Detachment Of Device Component 9 9
Inadequacy of Device Shape and/or Size 8 8
Difficult To Position 7 7
Disassembly 6 6
No Apparent Adverse Event 6 6
Component Missing 6 6
Material Erosion 6 6
Loss of Osseointegration 5 5
Material Deformation 5 5
Difficult to Remove 5 5
Metal Shedding Debris 4 4
Noise, Audible 4 4
Improper or Incorrect Procedure or Method 4 4
Contamination 3 3
Material Integrity Problem 3 3
Mechanical Jam 3 3
Mechanical Problem 3 3
Positioning Failure 2 2
Expulsion 2 2
Difficult to Advance 2 2
Device Contaminated During Manufacture or Shipping 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Physical Resistance/Sticking 2 2
Unintended Movement 2 2
Misconnection 2 2
Delivered as Unsterile Product 1 1
Device Appears to Trigger Rejection 1 1
Corroded 1 1
Difficult or Delayed Positioning 1 1
Tear, Rip or Hole in Device Packaging 1 1
Failure to Advance 1 1
Leak/Splash 1 1
Osseointegration Problem 1 1
Positioning Problem 1 1
Biocompatibility 1 1
Material Protrusion/Extrusion 1 1
Device Damaged by Another Device 1 1
Torn Material 1 1
Microbial Contamination of Device 1 1
Use of Device Problem 1 1
Structural Problem 1 1
Separation Failure 1 1
Patient-Device Incompatibility 1 1
Delamination 1 1
Material Fragmentation 1 1
Component Incompatible 1 1
Crack 1 1
Degraded 1 1
Particulates 1 1
Material Separation 1 1
Off-Label Use 1 1
Unclear Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 234 234
No Information 215 215
Unspecified Infection 215 215
Pain 159 159
Bone Fracture(s) 100 100
Failure of Implant 98 98
No Known Impact Or Consequence To Patient 74 74
Insufficient Information 60 60
Loss of Range of Motion 36 36
Osteolysis 32 32
Reaction 32 32
Fall 30 30
Tissue Damage 26 26
Nerve Damage 22 22
No Patient Involvement 20 20
Ossification 18 18
Injury 17 17
Death 15 15
No Consequences Or Impact To Patient 14 14
Ambulation Difficulties 12 12
Limited Mobility Of The Implanted Joint 12 12
Fracture, Arm 11 11
Joint Dislocation 10 10
Hematoma 10 10
Inflammation 10 10
Sleep Dysfunction 9 9
No Clinical Signs, Symptoms or Conditions 9 9
Necrosis 9 9
Device Embedded In Tissue or Plaque 8 8
Patient Problem/Medical Problem 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Swelling 8 8
Perforation 7 7
Discomfort 7 7
Post Operative Wound Infection 6 6
Peroneal Nerve Palsy 6 6
Muscle Weakness 6 6
Osteopenia/ Osteoporosis 5 5
Tingling 5 5
Fistula 5 5
Malunion of Bone 5 5
Foreign Body In Patient 4 4
Disability 4 4
Blood Loss 4 4
Synovitis 4 4
Neuropathy 4 4
Fever 3 3
Anemia 3 3
Tissue Breakdown 3 3
Inadequate Osseointegration 3 3
Cellulitis 3 3
Purulent Discharge 3 3
Impaired Healing 3 3
Joint Laxity 3 3
Adhesion(s) 2 2
Myocardial Infarction 2 2
Scar Tissue 2 2
Arthritis 2 2
Wound Dehiscence 2 2
Pulmonary Embolism 2 2
Erosion 2 2
Numbness 2 2
Rupture 2 2
Peritonitis 2 2
Fluid Discharge 1 1
Cyst(s) 1 1
Erythema 1 1
Abscess 1 1
Rheumatoid Arthritis 1 1
Irritation 1 1
Sepsis 1 1
Joint Disorder 1 1
Pneumothorax 1 1
Local Reaction 1 1
Muscular Rigidity 1 1
Atrial Fibrillation 1 1
Bacterial Infection 1 1
Debris, Bone Shedding 1 1
Not Applicable 1 1
Test Result 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Zimmer Biomet, Inc. II Feb-05-2020
2 Zimmer Biomet, Inc. II Nov-07-2019
3 Zimmer Biomet, Inc. II Mar-14-2018
4 Zimmer Biomet, Inc. II Sep-08-2016
-
-