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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
BIOMET MANUFACTURING CORP.
  SUBSTANTIALLY EQUIVALENT 2
LIMACORPORATE S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER INC
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 79 79
2015 239 239
2016 176 176
2017 401 401
2018 244 244
2019 189 189
2020 179 179
2021 157 157
2022 128 128
2023 190 190
2024 60 80

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 455 455
Adverse Event Without Identified Device or Use Problem 381 401
Appropriate Term/Code Not Available 211 211
Fracture 197 197
Loose or Intermittent Connection 171 171
Loosening of Implant Not Related to Bone-Ingrowth 135 155
Migration or Expulsion of Device 128 128
Naturally Worn 114 114
Device Dislodged or Dislocated 82 82
Failure To Adhere Or Bond 80 80
Break 50 50
Device Slipped 41 41
Unstable 37 37
Detachment of Device or Device Component 31 31
Migration 30 30
Malposition of Device 22 22
Loss of or Failure to Bond 20 20
Difficult to Insert 20 20
Packaging Problem 20 20
Device Markings/Labelling Problem 18 18
Disassembly 16 16
Device Operates Differently Than Expected 12 12
Inadequacy of Device Shape and/or Size 12 12
Detachment Of Device Component 11 11
Component Missing 10 10
Metal Shedding Debris 9 9
Improper or Incorrect Procedure or Method 8 8
Loss of Osseointegration 8 8
Difficult To Position 7 7
Noise, Audible 7 7
No Apparent Adverse Event 7 7
Patient Device Interaction Problem 6 6
Material Erosion 6 6
Material Deformation 6 6
Material Integrity Problem 6 6
Use of Device Problem 5 5
Difficult to Remove 5 5
Mechanical Problem 4 4
Positioning Problem 4 4
Unintended Movement 4 4
Misconnection 3 3
Fitting Problem 3 3
Degraded 3 3
Contamination 3 3
Material Protrusion/Extrusion 3 3
Mechanical Jam 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Osseointegration Problem 3 3
Device Contaminated During Manufacture or Shipping 2 2
Expulsion 2 2
Difficult to Advance 2 2
Material Separation 2 2
Off-Label Use 2 2
Positioning Failure 2 2
Peeled/Delaminated 2 2
Physical Resistance/Sticking 2 2
Unclear Information 1 1
Radiation Overexposure 1 1
Torn Material 1 1
Delivered as Unsterile Product 1 1
Particulates 1 1
Device Appears to Trigger Rejection 1 1
Device Damaged Prior to Use 1 1
Microbial Contamination of Device 1 1
Corroded 1 1
Crack 1 1
Component Falling 1 1
Component Incompatible 1 1
Difficult or Delayed Positioning 1 1
Leak/Splash 1 1
Material Fragmentation 1 1
Difficult to Open or Close 1 1
Device Disinfection Or Sterilization Issue 1 1
Human-Device Interface Problem 1 1
Mechanics Altered 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 Operational Issue 1 1
Device Damaged by Another Device 1 1
Patient-Device Incompatibility 1 1
Biocompatibility 1 1
Deformation Due to Compressive Stress 1 1
Connection Problem 1 1
Delamination 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 348 368
No Code Available 308 308
No Information 303 303
Pain 227 227
Failure of Implant 194 194
Bone Fracture(s) 186 186
Insufficient Information 117 117
Joint Laxity 83 83
No Known Impact Or Consequence To Patient 81 81
Loss of Range of Motion 65 65
Osteolysis 41 41
Fall 40 40
Joint Dislocation 37 37
Reaction 35 35
Nerve Damage 32 32
Ossification 27 27
Tissue Damage 27 27
No Clinical Signs, Symptoms or Conditions 22 22
No Consequences Or Impact To Patient 21 21
No Patient Involvement 20 20
Injury 18 18
Death 16 16
Osteopenia/ Osteoporosis 14 14
Limited Mobility Of The Implanted Joint 13 13
Ambulation Difficulties 13 13
Implant Pain 13 13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
Fracture, Arm 12 12
Hematoma 11 11
Peripheral Nervous Injury 11 31
Post Operative Wound Infection 11 11
Necrosis 10 10
Inflammation 10 10
Muscle Weakness 9 9
Wound Dehiscence 9 9
Sleep Dysfunction 9 9
Device Embedded In Tissue or Plaque 9 9
Metal Related Pathology 8 8
Inadequate Osseointegration 8 8
Patient Problem/Medical Problem 8 8
Numbness 8 8
Swelling 8 8
Perforation 8 8
Synovitis 7 7
Impaired Healing 7 7
Discomfort 7 7
Swelling/ Edema 7 7
Limb Fracture 6 6
Foreign Body In Patient 6 6
Peroneal Nerve Palsy 6 6
Tingling 5 5
Scar Tissue 5 5
Fistula 5 5
Hypersensitivity/Allergic reaction 5 5
Adhesion(s) 5 5
Tissue Breakdown 5 5
Cramp(s) /Muscle Spasm(s) 5 5
Malunion of Bone 5 5
Muscle/Tendon Damage 4 4
Test Result 4 4
Blood Loss 4 4
Bacterial Infection 4 4
Neuropathy 4 4
Disability 4 4
Non-union Bone Fracture 3 3
Rupture 3 3
Anemia 3 3
Arthritis 3 3
Rheumatoid Arthritis 3 3
Cellulitis 3 3
Fever 3 3
Purulent Discharge 3 3
Fluid Discharge 3 3
Decreased Sensitivity 2 2
Unequal Limb Length 2 2
Joint Contracture 2 2
Erosion 2 2
Pulmonary Embolism 2 2
Abscess 2 2
Myocardial Infarction 2 2
Peritonitis 2 2
Sepsis 2 2
Seroma 2 2
Local Reaction 2 2
Complaint, Ill-Defined 2 2
Toxicity 1 1
Arthralgia 1 1
Joint Swelling 1 1
Joint Disorder 1 1
Pneumothorax 1 1
Paralysis 1 1
Physical Entrapment 1 1
Undesired Nerve Stimulation 1 1
Muscular Rigidity 1 1
Irritation 1 1
Hyperglycemia 1 1
Micturition Urgency 1 1
Atrial Fibrillation 1 1
Erythema 1 1
Cyst(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Jun-26-2014
2 Biomet, Inc. II Feb-21-2012
3 Biomet, Inc. II Jun-24-2011
4 Limacorporate S.p.A II Mar-16-2023
5 Zimmer Biomet, Inc. II Feb-05-2020
6 Zimmer Biomet, Inc. II Nov-07-2019
7 Zimmer Biomet, Inc. II Mar-14-2018
8 Zimmer Biomet, Inc. II Sep-08-2016
9 Zimmer Inc. II Apr-02-2009
10 Zimmer, Inc. II Dec-18-2012
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