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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
2018 244 244
2019 189 189
2020 179 179
2021 157 157
2022 128 128
2023 150 150

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 256 256
Appropriate Term/Code Not Available 162 162
Insufficient Information 140 140
Loosening of Implant Not Related to Bone-Ingrowth 107 107
Loose or Intermittent Connection 103 103
Fracture 102 102
Naturally Worn 71 71
Device Dislodged or Dislocated 50 50
Migration or Expulsion of Device 31 31
Migration 30 30
Detachment of Device or Device Component 28 28
Break 19 19
Unstable 17 17
Malposition of Device 17 17
Loss of or Failure to Bond 14 14
Difficult to Insert 12 12
Loss of Osseointegration 7 7
Device Slipped 7 7
No Apparent Adverse Event 7 7
Patient Device Interaction Problem 5 5
Unintended Movement 4 4
Inadequacy of Device Shape and/or Size 4 4
Use of Device Problem 4 4
Material Erosion 4 4
Disassembly 3 3
Degraded 3 3
Metal Shedding Debris 3 3
Misconnection 3 3
Mechanical Jam 3 3
Osseointegration Problem 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Material Integrity Problem 3 3
Noise, Audible 3 3
Physical Resistance/Sticking 2 2
Material Protrusion/Extrusion 2 2
Expulsion 2 2
Device Contaminated During Manufacture or Shipping 2 2
Device Operates Differently Than Expected 2 2
Packaging Problem 2 2
Positioning Problem 2 2
Difficult to Advance 2 2
Peeled/Delaminated 2 2
Positioning Failure 2 2
Contamination 2 2
Mechanical Problem 2 2
Leak/Splash 1 1
Material Fragmentation 1 1
Corroded 1 1
Crack 1 1
Difficult or Delayed Positioning 1 1
Off-Label Use 1 1
Device Appears to Trigger Rejection 1 1
Difficult to Remove 1 1
Material Separation 1 1
Delivered as Unsterile Product 1 1
Improper or Incorrect Procedure or Method 1 1
Microbial Contamination of Device 1 1
Component Missing 1 1
Tear, Rip or Hole in Device Packaging 1 1
Structural Problem 1 1
Failure to Advance 1 1
Separation Failure 1 1
Device Damaged by Another Device 1 1
Patient-Device Incompatibility 1 1
Unclear Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure of Implant 165 165
Unspecified Infection 165 165
Pain 133 133
No Information 110 110
Insufficient Information 101 101
No Code Available 93 93
Bone Fracture(s) 83 83
Joint Laxity 58 58
No Known Impact Or Consequence To Patient 52 52
Loss of Range of Motion 37 37
Joint Dislocation 28 28
No Clinical Signs, Symptoms or Conditions 21 21
Fall 20 20
Reaction 15 15
Osteolysis 14 14
Osteopenia/ Osteoporosis 13 13
Ambulation Difficulties 12 12
Injury 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
Tissue Damage 11 11
No Consequences Or Impact To Patient 10 10
Sleep Dysfunction 9 9
Wound Dehiscence 9 9
Ossification 9 9
Hematoma 8 8
Inadequate Osseointegration 8 8
Metal Related Pathology 8 8
Limited Mobility Of The Implanted Joint 7 7
Swelling 7 7
Nerve Damage 7 7
Death 6 6
Fracture, Arm 6 6
Peroneal Nerve Palsy 6 6
Impaired Healing 6 6
Numbness 6 6
Peripheral Nervous Injury 6 6
Device Embedded In Tissue or Plaque 6 6
Implant Pain 6 6
Swelling/ Edema 6 6
Patient Problem/Medical Problem 5 5
Malunion of Bone 5 5
Discomfort 5 5
Tissue Breakdown 5 5
Tingling 5 5
Adhesion(s) 5 5
Inflammation 5 5
Scar Tissue 5 5
Neuropathy 4 4
Fistula 4 4
Synovitis 4 4
Disability 4 4
Limb Fracture 4 4
Foreign Body In Patient 4 4
Blood Loss 4 4
Post Operative Wound Infection 3 3
Necrosis 3 3
Anemia 3 3
Arthritis 3 3
Bacterial Infection 3 3
Cellulitis 3 3
Fever 3 3
Muscle/Tendon Damage 3 3
Joint Contracture 2 2
Hypersensitivity/Allergic reaction 2 2
Rheumatoid Arthritis 2 2
Myocardial Infarction 2 2
Local Reaction 2 2
Perforation 2 2
Seroma 2 2
Peritonitis 2 2
Non-union Bone Fracture 2 2
Decreased Sensitivity 2 2
No Patient Involvement 2 2
Fluid Discharge 1 1
Arthralgia 1 1
Joint Disorder 1 1
Pneumothorax 1 1
Paralysis 1 1
Sepsis 1 1
Muscular Rigidity 1 1
Atrial Fibrillation 1 1
Erosion 1 1
Pulmonary Embolism 1 1
Cyst(s) 1 1
Debris, Bone Shedding 1 1
Erythema 1 1
Not Applicable 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
4 Zimmer Biomet, Inc. II Mar-14-2018
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