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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
2019 245 245
2020 185 185
2021 133 133
2022 128 128
2023 255 256
2024 80 80

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult to Insert 264 264
Adverse Event Without Identified Device or Use Problem 154 154
Fracture 140 140
Positioning Failure 90 90
Device Dislodged or Dislocated 85 86
Material Deformation 34 34
Detachment of Device or Device Component 33 33
Separation Failure 28 28
Device Contaminated During Manufacture or Shipping 28 28
Insufficient Information 26 26
Packaging Problem 21 21
Difficult to Remove 20 20
Loosening of Implant Not Related to Bone-Ingrowth 19 19
Naturally Worn 15 15
Noise, Audible 13 13
Difficult or Delayed Separation 13 13
Unstable 13 13
Material Erosion 13 13
Delivered as Unsterile Product 10 10
Migration 10 10
Physical Resistance/Sticking 9 9
Unintended Movement 7 7
Positioning Problem 6 6
Mechanical Problem 6 6
Break 6 6
Degraded 6 6
Peeled/Delaminated 5 5
Tear, Rip or Hole in Device Packaging 5 5
Loss of or Failure to Bond 5 5
Activation, Positioning or Separation Problem 5 5
Material Twisted/Bent 5 5
Manufacturing, Packaging or Shipping Problem 5 5
Patient Device Interaction Problem 4 4
Difficult or Delayed Positioning 4 4
Migration or Expulsion of Device 4 4
Malposition of Device 3 3
Off-Label Use 3 3
Separation Problem 3 3
Device Damaged by Another Device 2 2
Unsealed Device Packaging 2 2
Flaked 2 2
Material Disintegration 2 2
Corroded 1 1
Material Fragmentation 1 1
Nonstandard Device 1 1
Shipping Damage or Problem 1 1
Problem with Sterilization 1 1
Use of Device Problem 1 1
Failure to Osseointegrate 1 1
Fitting Problem 1 1
Device Damaged Prior to Use 1 1
Component Missing 1 1
Device Markings/Labelling Problem 1 1
Failure to Advance 1 1
Defective Device 1 1
Device-Device Incompatibility 1 1
Compatibility Problem 1 1
Material Integrity Problem 1 1
Mechanical Jam 1 1
Scratched Material 1 1
Osseointegration Problem 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 352 352
No Known Impact Or Consequence To Patient 164 164
Pain 103 103
Joint Dislocation 83 84
No Information 48 48
Unspecified Infection 48 48
No Consequences Or Impact To Patient 39 40
No Code Available 36 36
Failure of Implant 35 35
No Patient Involvement 31 31
Bone Fracture(s) 25 25
Fall 24 24
Insufficient Information 24 24
Ambulation Difficulties 20 20
Wound Dehiscence 15 15
Foreign Body In Patient 14 14
Loss of Range of Motion 12 12
Hemorrhage/Bleeding 11 11
Impaired Healing 10 10
Metal Related Pathology 9 9
Patient Problem/Medical Problem 8 8
Inflammation 8 8
Tissue Damage 8 8
Bacterial Infection 8 8
Limited Mobility Of The Implanted Joint 7 7
Subluxation 7 7
Osteolysis 7 7
Blood Loss 5 5
Ossification 5 5
Death 5 5
Scar Tissue 5 5
Swelling/ Edema 5 5
Low Blood Pressure/ Hypotension 4 4
Device Embedded In Tissue or Plaque 4 4
Osteopenia/ Osteoporosis 3 3
Sleep Dysfunction 3 3
Cellulitis 3 3
Local Reaction 3 3
Hematoma 3 3
Pulmonary Embolism 3 3
Host-Tissue Reaction 3 3
Anemia 3 3
Thrombosis/Thrombus 3 3
Unspecified Tissue Injury 3 3
Arrhythmia 2 2
Fatigue 2 2
Embolism 2 2
Weakness 2 2
Swelling 2 2
Neck Stiffness 2 2
Hypovolemia 2 2
Muscle/Tendon Damage 2 2
Unequal Limb Length 2 2
Joint Laxity 1 1
Convulsion/Seizure 1 1
Syncope/Fainting 1 1
Peripheral Nervous Injury 1 1
Thromboembolism 1 1
Distress 1 1
Discomfort 1 1
Reaction 1 1
Post Operative Wound Infection 1 1
Cognitive Changes 1 1
Confusion/ Disorientation 1 1
Inadequate Osseointegration 1 1
Hot Flashes/Flushes 1 1
Scarring 1 1
Seroma 1 1
Staphylococcus Aureus 1 1
Rash 1 1
Muscle Weakness 1 1
Myocardial Infarction 1 1
Neuropathy 1 1
Erythema 1 1
Dementia 1 1
Erosion 1 1
Bruise/Contusion 1 1
Abrasion 1 1

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