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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 190 190
2024 87 112

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 321 341
Appropriate Term/Code Not Available 148 148
Loosening of Implant Not Related to Bone-Ingrowth 134 159
Fracture 88 88
Loose or Intermittent Connection 78 78
Insufficient Information 74 74
Naturally Worn 53 53
Device Dislodged or Dislocated 41 41
Detachment of Device or Device Component 29 29
Unstable 21 21
Migration 21 21
Break 19 19
Loss of or Failure to Bond 14 14
Migration or Expulsion of Device 12 12
Malposition of Device 9 9
No Apparent Adverse Event 8 8
Loss of Osseointegration 7 7
Difficult to Insert 7 7
Patient Device Interaction Problem 6 6
Use of Device Problem 5 5
Inadequacy of Device Shape and/or Size 4 4
Device Slipped 4 4
Unintended Movement 4 4
Material Integrity Problem 3 3
Osseointegration Problem 3 3
Material Erosion 3 3
Degraded 3 3
Positioning Failure 2 2
Peeled/Delaminated 2 2
Improper or Incorrect Procedure or Method 2 2
Expulsion 2 2
Packaging Problem 2 2
Material Protrusion/Extrusion 2 2
Mechanical Jam 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Noise, Audible 2 2
Unclear Information 1 1
Positioning Problem 1 1
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

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure of Implant 165 170
Unspecified Infection 165 190
Insufficient Information 118 118
Pain 115 115
Joint Laxity 91 91
Bone Fracture(s) 80 80
No Information 62 62
No Known Impact Or Consequence To Patient 46 46
Loss of Range of Motion 38 38
No Code Available 33 33
Joint Dislocation 30 30
No Clinical Signs, Symptoms or Conditions 24 24
Fall 21 21
Implant Pain 15 15
Osteopenia/ Osteoporosis 14 14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
Osteolysis 11 11
Injury 11 11
Peripheral Nervous Injury 11 31
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
Limb Fracture 7 7
Limited Mobility Of The Implanted Joint 7 7
Tissue Damage 7 7
Nerve Damage 7 7
Impaired Healing 6 6
Numbness 6 6
Post Operative Wound Infection 5 5
Fracture, Arm 5 5
Tissue Breakdown 5 5
Cramp(s) /Muscle Spasm(s) 5 5
Patient Problem/Medical Problem 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
Muscle/Tendon Damage 4 4
Blood Loss 4 4
Peroneal Nerve Palsy 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
Rheumatoid Arthritis 2 2
Necrosis 2 2
Local Reaction 2 2
Perforation 2 2
Seroma 2 2
Unequal Limb Length 2 2
Device Embedded In Tissue or Plaque 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
Subluxation 1 1
Pneumothorax 1 1
Paralysis 1 1
Erosion 1 1
Cyst(s) 1 1
Debris, Bone Shedding 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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