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

MDR Year MDR Reports MDR Events
2020 179 179
2021 157 157
2022 130 130
2023 190 190
2024 176 216
2025 63 63

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 395 430
Loosening of Implant Not Related to Bone-Ingrowth 139 164
Appropriate Term/Code Not Available 118 118
Fracture 81 81
Loose or Intermittent Connection 62 62
Naturally Worn 48 48
Insufficient Information 41 41
Device Dislodged or Dislocated 39 39
Unstable 30 30
Detachment of Device or Device Component 26 26
Migration 16 16
Break 13 13
Material Erosion 10 10
Patient Device Interaction Problem 9 9
Malposition of Device 7 7
Difficult to Insert 7 7
Loss of Osseointegration 6 6
Migration or Expulsion of Device 4 4
Loss of or Failure to Bond 4 4
Use of Device Problem 4 4
Osseointegration Problem 3 3
Unintended Movement 3 3
Improper or Incorrect Procedure or Method 3 3
Inadequacy of Device Shape and/or Size 3 3
Noise, Audible 2 2
Mechanical Jam 2 2
No Apparent Adverse Event 2 2
Material Protrusion/Extrusion 2 2
Tear, Rip or Hole in Device Packaging 2 2
Packaging Problem 2 2
Positioning Failure 2 2
Degraded 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Peeled/Delaminated 2 2
Expulsion 2 2
Device Slipped 2 2
Misconnection 1 1
Component Missing 1 1
Material Separation 1 1
Material Fragmentation 1 1
Positioning Problem 1 1
Material Integrity Problem 1 1
Difficult to Open or Close 1 1
Patient-Device Incompatibility 1 1
Device Markings/Labelling Problem 1 1
Deformation Due to Compressive Stress 1 1
Off-Label Use 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure of Implant 184 189
Unspecified Infection 160 200
Insufficient Information 144 144
Joint Laxity 136 136
Pain 100 100
Bone Fracture(s) 79 79
Loss of Range of Motion 41 41
Joint Dislocation 33 33
No Clinical Signs, Symptoms or Conditions 33 33
Fall 20 20
Implant Pain 18 18
Swelling/ Edema 14 14
No Code Available 14 14
No Information 14 14
Peripheral Nervous Injury 13 33
Osteolysis 13 13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
No Known Impact Or Consequence To Patient 12 12
Ossification 11 11
Osteopenia/ Osteoporosis 11 11
Metal Related Pathology 10 10
Muscle/Tendon Damage 9 9
Limb Fracture 9 9
Numbness 9 9
Injury 9 9
Impaired Healing 9 9
Bacterial Infection 8 8
Scar Tissue 8 8
Inadequate Osseointegration 8 8
Wound Dehiscence 7 7
Adhesion(s) 7 7
Nerve Damage 7 7
Reaction 6 6
Hematoma 6 6
Tissue Breakdown 5 5
Malunion of Bone 5 5
Limited Mobility Of The Implanted Joint 5 5
Inflammation 5 5
Post Operative Wound Infection 5 5
Muscle Weakness 5 5
Cramp(s) /Muscle Spasm(s) 5 5
Synovitis 5 5
Hypersensitivity/Allergic reaction 4 4
Patient Problem/Medical Problem 4 4
Tissue Damage 4 4
No Consequences Or Impact To Patient 4 4
Nodule 3 3
Fracture, Arm 3 3
Arthritis 3 3
Foreign Body In Patient 2 2

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