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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, metatarsophalangeal joint cartilage replacement implant
Definition The device is a metatarsophalangeal joint cartilage replacement device that is implanted in the metatarsal head of the first metatarsophalangeal joint.
Product CodePNW
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 0 0 0 0 0 4 3 3 4 1 1 0 0 0

MDR Year MDR Reports MDR Events
2016 1 1
2017 7 7
2018 13 13
2019 44 44
2020 36 36
2021 28 28
2022 94 94
2023 19 19
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 108 108
Insufficient Information 33 33
Migration 27 27
Unintended Movement 13 13
Patient Device Interaction Problem 9 9
Degraded 8 8
Material Fragmentation 8 8
Therapeutic or Diagnostic Output Failure 7 7
Material Integrity Problem 6 6
Malposition of Device 6 6
Loosening of Implant Not Related to Bone-Ingrowth 6 6
Patient-Device Incompatibility 4 4
Break 4 4
Fracture 3 3
Device Dislodged or Dislocated 3 3
Naturally Worn 3 3
Delivered as Unsterile Product 2 2
Failure to Osseointegrate 2 2
Appropriate Term/Code Not Available 2 2
Noise, Audible 1 1
Material Split, Cut or Torn 1 1
Unclear Information 1 1
Device Appears to Trigger Rejection 1 1
Inadequacy of Device Shape and/or Size 1 1
Unexpected Therapeutic Results 1 1
Material Erosion 1 1
Material Deformation 1 1
Biocompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 128 128
Loss of Range of Motion 33 33
Failure of Implant 25 25
Insufficient Information 22 22
Implant Pain 20 20
Ambulation Difficulties 14 14
No Clinical Signs, Symptoms or Conditions 12 12
Unspecified Infection 11 11
Inflammation 11 11
Swelling/ Edema 10 10
Discomfort 9 9
Swelling 9 9
Joint Swelling 7 7
Nerve Damage 7 7
No Code Available 5 5
No Information 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Cyst(s) 4 4
Patient Problem/Medical Problem 4 4
Osteolysis 4 4
Inadequate Pain Relief 3 3
Irritability 3 3
Arthritis 3 3
Erosion 3 3
Bone Fracture(s) 3 3
Hypersensitivity/Allergic reaction 2 2
Foreign Body Reaction 2 2
Post Operative Wound Infection 2 2
No Known Impact Or Consequence To Patient 2 2
Synovitis 2 2
Limited Mobility Of The Implanted Joint 2 2
Joint Laxity 2 2
Skin Inflammation/ Irritation 1 1
No Consequences Or Impact To Patient 1 1
Therapeutic Response, Decreased 1 1
Reaction 1 1
Fungal Infection 1 1
Device Embedded In Tissue or Plaque 1 1
Weight Changes 1 1
Inadequate Osseointegration 1 1
Sleep Dysfunction 1 1
Joint Dislocation 1 1
Bacterial Infection 1 1
Purulent Discharge 1 1
Edema 1 1
Fall 1 1
High Blood Pressure/ Hypertension 1 1
Local Reaction 1 1

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