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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive
Definition For use as a component of a total hip prosthesis in primary and revision patients at high risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability, and for whom all other options to constrained acetabular components have been considered.
Product CodePBI
Regulation Number 888.3310
Device Class 2


Premarket Reviews
ManufacturerDecision
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 231 231
2018 278 278
2019 245 245
2020 185 185
2021 133 133
2022 73 73

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult to Insert 335 335
Fracture 121 121
Adverse Event Without Identified Device or Use Problem 115 115
Insufficient Information 106 106
Positioning Failure 81 81
Device Dislodged or Dislocated 79 79
Difficult To Position 60 60
Device Contaminated During Manufacture or Shipping 38 38
Packaging Problem 34 34
Detachment of Device or Device Component 31 31
Fitting Problem 30 30
Separation Failure 21 21
Migration or Expulsion of Device 18 18
Difficult to Remove 16 16
Material Deformation 15 15
Positioning Problem 14 14
Device-Device Incompatibility 14 14
Delivered as Unsterile Product 13 13
Device Packaging Compromised 11 11
Noise, Audible 11 11
Difficult or Delayed Separation 11 11
Tear, Rip or Hole in Device Packaging 10 10
Unstable 10 10
Difficult or Delayed Positioning 10 10
Unsealed Device Packaging 9 9
Loosening of Implant Not Related to Bone-Ingrowth 9 9
Migration 9 9
Appropriate Term/Code Not Available 8 8
Malposition of Device 6 6
Mechanical Problem 5 5
Unintended Movement 5 5
Naturally Worn 5 5
Peeled/Delaminated 5 5
Material Erosion 5 5
Loss of or Failure to Bond 5 5
Corroded 5 5
Disassembly 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Patient Device Interaction Problem 4 4
Material Twisted/Bent 3 3
Device Contamination with Chemical or Other Material 3 3
Difficult to Open or Remove Packaging Material 3 3
Defective Device 3 3
Device Markings/Labelling Problem 3 3
Break 3 3
Detachment Of Device Component 2 2
Bent 2 2
Degraded 2 2
Disconnection 2 2
Material Disintegration 2 2
Flaked 2 2
Misassembled 2 2
Loose or Intermittent Connection 2 2
Device Damaged Prior to Use 2 2
Material Separation 2 2
Device Damaged by Another Device 2 2
Activation, Positioning or SeparationProblem 2 2
Component or Accessory Incompatibility 1 1
Failure to Align 1 1
Failure to Advance 1 1
Difficult to Open or Close 1 1
Device Operates Differently Than Expected 1 1
Device Disinfection Or Sterilization Issue 1 1
Osseointegration Problem 1 1
Compatibility Problem 1 1
Installation-Related Problem 1 1
Mechanical Jam 1 1
Shipping Damage or Problem 1 1
Problem with Sterilization 1 1
Sticking 1 1
Component Missing 1 1
Metal Shedding Debris 1 1
Failure to Osseointegrate 1 1
Material Fragmentation 1 1
Misconnection 1 1
Filling Problem 1 1
Entrapment of Device 1 1
Material Discolored 1 1
Crack 1 1
Component Falling 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 290 290
No Information 153 153
No Clinical Signs, Symptoms or Conditions 127 127
Pain 127 127
No Code Available 88 88
No Consequences Or Impact To Patient 85 86
Joint Dislocation 75 75
Unspecified Infection 63 63
No Patient Involvement 54 54
Ambulation Difficulties 26 26
Bone Fracture(s) 23 23
Fall 17 17
Wound Dehiscence 15 15
Loss of Range of Motion 15 15
Blood Loss 14 14
Impaired Healing 12 12
Failure of Implant 12 12
Tissue Damage 11 11
Limited Mobility Of The Implanted Joint 10 10
Swelling 9 9
Hematoma 9 9
Bacterial Infection 8 8
Foreign Body In Patient 8 8
Patient Problem/Medical Problem 8 8
Discomfort 7 7
Death 7 7
Device Embedded In Tissue or Plaque 6 6
Metal Related Pathology 5 5
Insufficient Information 4 4
Ossification 4 4
Host-Tissue Reaction 3 3
Anemia 3 3
Low Blood Pressure/ Hypotension 3 3
Local Reaction 3 3
Staphylococcus Aureus 3 3
Inflammation 3 3
Weakness 3 3
Post Operative Wound Infection 3 3
Sleep Dysfunction 2 2
Lethargy 2 2
Hypovolemia 2 2
Neck Stiffness 2 2
Sweating 2 2
Subluxation 2 2
Unspecified Tissue Injury 2 2
Cancer 2 2
Chills 2 2
Scarring 2 2
Embolism 2 2
Arrhythmia 2 2
Cellulitis 2 2
Fatigue 2 2
Fever 2 2
Granuloma 2 2
Chest Pain 1 1
Dementia 1 1
Erosion 1 1
Pulmonary Embolism 1 1
Abrasion 1 1
Scar Tissue 1 1
Muscle Spasm(s) 1 1
Rupture 1 1
Discharge 1 1
Convulsion/Seizure 1 1
Peripheral Nervous Injury 1 1
Muscle/Tendon Damage 1 1
Unequal Limb Length 1 1
Reaction 1 1
Numbness 1 1
Inadequate Osseointegration 1 1
Osteopenia/ Osteoporosis 1 1
Claudication 1 1
Confusion/ Disorientation 1 1

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