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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, elbow, constrained, cemented
Product CodeJDC
Regulation Number 888.3150
Device Class 2


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

MDR Year MDR Reports MDR Events
2017 401 401
2018 243 243
2019 189 189
2020 179 179
2021 157 157
2022 91 91

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 294 294
Appropriate Term/Code Not Available 180 180
Adverse Event Without Identified Device or Use Problem 160 160
Loose or Intermittent Connection 120 120
Fracture 118 118
Migration or Expulsion of Device 108 108
Loosening of Implant Not Related to Bone-Ingrowth 94 94
Naturally Worn 78 78
Device Dislodged or Dislocated 42 42
Unstable 27 27
Migration 26 26
Break 23 23
Detachment of Device or Device Component 20 20
Packaging Problem 19 19
Device Markings/Labelling Problem 18 18
Loss of or Failure to Bond 17 17
Malposition of Device 16 16
Difficult to Insert 14 14
Device Slipped 13 13
Inadequacy of Device Shape and/or Size 11 11
Detachment Of Device Component 8 8
Difficult To Position 7 7
Device Operates Differently Than Expected 7 7
No Apparent Adverse Event 6 6
Noise, Audible 5 5
Material Deformation 5 5
Component Missing 5 5
Loss of Osseointegration 5 5
Disassembly 5 5
Material Erosion 5 5
Failure To Adhere Or Bond 4 4
Difficult to Remove 4 4
Improper or Incorrect Procedure or Method 4 4
Metal Shedding Debris 3 3
Misconnection 3 3
Contamination 3 3
Material Integrity Problem 3 3
Material Protrusion/Extrusion 3 3
Mechanical Jam 3 3
Patient Device Interaction Problem 3 3
Unintended Movement 3 3
Positioning Problem 2 2
Difficult to Advance 2 2
Osseointegration Problem 2 2
Expulsion 2 2
Device Contaminated During Manufacture or Shipping 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Degraded 2 2
Mechanical Problem 2 2
Off-Label Use 2 2
Positioning Failure 2 2
Use of Device Problem 2 2
Physical Resistance/Sticking 2 2
Unclear Information 1 1
Microbial Contamination of Device 1 1
Device Appears to Trigger Rejection 1 1
Material Separation 1 1
Delivered as Unsterile Product 1 1
Peeled/Delaminated 1 1
Leak/Splash 1 1
Material Fragmentation 1 1
Difficult or Delayed Positioning 1 1
Corroded 1 1
Crack 1 1
Device Damaged by Another Device 1 1
Structural Problem 1 1
Failure to Advance 1 1
Separation Failure 1 1
Tear, Rip or Hole in Device Packaging 1 1
Patient-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 200 200
No Code Available 185 185
No Information 179 179
Pain 154 154
Failure of Implant 137 137
Bone Fracture(s) 99 99
Insufficient Information 86 86
No Known Impact Or Consequence To Patient 67 67
Loss of Range of Motion 38 38
Osteolysis 31 31
Fall 28 28
Reaction 27 27
Tissue Damage 25 25
Nerve Damage 24 24
No Patient Involvement 20 20
Ossification 19 19
Joint Dislocation 16 16
Death 15 15
Injury 14 14
Osteopenia/ Osteoporosis 12 12
Limited Mobility Of The Implanted Joint 12 12
Ambulation Difficulties 12 12
No Consequences Or Impact To Patient 11 11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 11 11
No Clinical Signs, Symptoms or Conditions 10 10
Fracture, Arm 10 10
Inflammation 10 10
Hematoma 9 9
Necrosis 9 9
Sleep Dysfunction 9 9
Patient Problem/Medical Problem 8 8
Swelling 8 8
Perforation 8 8
Discomfort 7 7
Impaired Healing 7 7
Device Embedded In Tissue or Plaque 7 7
Joint Laxity 6 6
Peroneal Nerve Palsy 6 6
Muscle Weakness 6 6
Wound Dehiscence 6 6
Tingling 5 5
Post Operative Wound Infection 5 5
Foreign Body In Patient 5 5
Malunion of Bone 5 5
Metal Related Pathology 4 4
Tissue Breakdown 4 4
Blood Loss 4 4
Scar Tissue 4 4
Disability 4 4
Fistula 4 4
Neuropathy 4 4
Anemia 3 3
Cellulitis 3 3
Fever 3 3
Purulent Discharge 3 3
Synovitis 3 3
Inadequate Osseointegration 3 3
Swelling/ Edema 3 3
Peripheral Nervous Injury 2 2
Decreased Sensitivity 2 2
Fluid Discharge 2 2
Numbness 2 2
Rupture 2 2
Peritonitis 2 2
Arthritis 2 2
Adhesion(s) 2 2
Myocardial Infarction 2 2
Pneumothorax 1 1
Paralysis 1 1
Muscular Rigidity 1 1
Pulmonary Embolism 1 1
Abscess 1 1
Rheumatoid Arthritis 1 1
Atrial Fibrillation 1 1
Erosion 1 1
Erythema 1 1
Cyst(s) 1 1
Debris, Bone Shedding 1 1
Joint Disorder 1 1
Sepsis 1 1
Local Reaction 1 1
Limb Fracture 1 1
Implant Pain 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
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