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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
2019 189 189
2020 179 179
2021 157 157
2022 128 128
2023 187 187
2024 40 60

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 285 305
Appropriate Term/Code Not Available 148 148
Loosening of Implant Not Related to Bone-Ingrowth 130 150
Fracture 88 88
Loose or Intermittent Connection 78 78
Insufficient Information 73 73
Naturally Worn 53 53
Device Dislodged or Dislocated 38 38
Detachment of Device or Device Component 28 28
Unstable 20 20
Migration 20 20
Break 18 18
Loss of or Failure to Bond 14 14
Migration or Expulsion of Device 9 9
Malposition of Device 9 9
Loss of Osseointegration 7 7
Difficult to Insert 7 7
No Apparent Adverse Event 7 7
Patient Device Interaction Problem 6 6
Unintended Movement 4 4
Inadequacy of Device Shape and/or Size 4 4
Device Slipped 4 4
Use of Device Problem 4 4
Material Erosion 3 3
Degraded 3 3
Material Integrity Problem 3 3
Osseointegration Problem 3 3
Packaging Problem 2 2
Material Protrusion/Extrusion 2 2
Mechanical Jam 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Noise, Audible 2 2
Positioning Failure 2 2
Peeled/Delaminated 2 2
Improper or Incorrect Procedure or Method 2 2
Expulsion 2 2
Device Contaminated During Manufacture or Shipping 1 1
Device Damaged by Another Device 1 1
Difficult to Open or Close 1 1
Structural Problem 1 1
Patient-Device Incompatibility 1 1
Deformation Due to Compressive Stress 1 1
Microbial Contamination of Device 1 1
Component Missing 1 1
Tear, Rip or Hole in Device Packaging 1 1
Leak/Splash 1 1
Off-Label Use 1 1
Device Appears to Trigger Rejection 1 1
Material Separation 1 1
Misconnection 1 1
Delivered as Unsterile Product 1 1
Corroded 1 1
Crack 1 1
Material Fragmentation 1 1
Unclear Information 1 1
Positioning Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure of Implant 158 158
Unspecified Infection 152 172
Pain 114 114
Insufficient Information 113 113
Joint Laxity 77 77
Bone Fracture(s) 74 74
No Information 62 62
No Known Impact Or Consequence To Patient 46 46
Loss of Range of Motion 37 37
No Code Available 33 33
Joint Dislocation 26 26
No Clinical Signs, Symptoms or Conditions 22 22
Fall 20 20
Osteopenia/ Osteoporosis 13 13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
Implant Pain 12 12
Peripheral Nervous Injury 11 31
Osteolysis 11 11
Injury 11 11
Reaction 10 10
Wound Dehiscence 9 9
Ossification 8 8
No Consequences Or Impact To Patient 8 8
Inadequate Osseointegration 8 8
Metal Related Pathology 8 8
Swelling/ Edema 7 7
Limited Mobility Of The Implanted Joint 7 7
Tissue Damage 7 7
Nerve Damage 7 7
Numbness 6 6
Impaired Healing 6 6
Limb Fracture 6 6
Cramp(s) /Muscle Spasm(s) 5 5
Patient Problem/Medical Problem 5 5
Fracture, Arm 5 5
Tissue Breakdown 5 5
Scar Tissue 5 5
Synovitis 5 5
Adhesion(s) 5 5
Inflammation 5 5
Malunion of Bone 5 5
Fistula 4 4
Discomfort 4 4
Swelling 4 4
Hypersensitivity/Allergic reaction 4 4
Disability 4 4
Blood Loss 4 4
Peroneal Nerve Palsy 4 4
Muscle/Tendon Damage 4 4
Foreign Body In Patient 3 3
Hematoma 3 3
Muscle Weakness 3 3
Anemia 3 3
Arthritis 3 3
Bacterial Infection 3 3
Necrosis 2 2
Local Reaction 2 2
Perforation 2 2
Seroma 2 2
Device Embedded In Tissue or Plaque 2 2
Unequal Limb Length 2 2
Joint Contracture 2 2
Non-union Bone Fracture 2 2
No Patient Involvement 2 2
Decreased Sensitivity 2 2
Fluid Discharge 1 1
Arthralgia 1 1
Ambulation Difficulties 1 1
Pneumothorax 1 1
Paralysis 1 1
Erosion 1 1
Cyst(s) 1 1
Debris, Bone Shedding 1 1
Rheumatoid Arthritis 1 1
Muscular Rigidity 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Limacorporate S.p.A II Mar-16-2023
2 Zimmer Biomet, Inc. II Feb-05-2020
3 Zimmer Biomet, Inc. II Nov-07-2019
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