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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device semi-constrained metal/polymer finger joint prosthesis
Product CodeMPK
Device Class Humanitarian Device Exemption

MDR Year MDR Reports MDR Events
2019 11 11
2020 29 29
2021 2 2
2022 2 2
2023 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 31 31
Naturally Worn 8 8
Device Dislodged or Dislocated 5 5
Loss of Osseointegration 3 3
Loose or Intermittent Connection 2 2
Migration 2 2
Device Slipped 1 1
Component Missing 1 1
Break 1 1
Fracture 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 22 22
Injury 20 20
Inflammation 8 8
No Known Impact Or Consequence To Patient 7 7
Failure of Implant 5 5
Ossification 5 5
Hypoesthesia, Arm/Hand 4 4
Bone Fracture(s) 4 4
Insufficient Information 4 4
Nerve Damage 3 3
Joint Laxity 3 3
Unspecified Infection 2 2
Joint Dislocation 2 2
Death 1 1
Foreign Body In Patient 1 1
No Code Available 1 1
Swelling 1 1
Loss of Range of Motion 1 1
Discomfort 1 1
Numbness 1 1
Debris, Bone Shedding 1 1
Osteolysis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Wright Medical Technology, Inc. II Aug-23-2022
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