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TPLC
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show TPLC since
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Device
prosthesis, toe (metatarsophalangeal), joint, metal/polymer, semi-constrained
Product Code
LZJ
Device Class
Unclassified
Premarket Reviews
Manufacturer
Decision
ARTHROSURFACE, INC.
SUBSTANTIALLY EQUIVALENT
1
ASCENSION ORTHOPEDICS, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
3
3
2015
5
5
2016
4
4
2017
2
2
2018
11
11
2019
3
3
2020
1
1
2021
2
2
2022
1
1
2023
7
7
2024
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Loose or Intermittent Connection
10
10
Adverse Event Without Identified Device or Use Problem
8
8
Insufficient Information
3
3
Therapeutic or Diagnostic Output Failure
2
2
Unintended Movement
2
2
Break
2
2
Device Operates Differently Than Expected
2
2
Migration or Expulsion of Device
2
2
Peeled/Delaminated
2
2
Unstable
1
1
Dull, Blunt
1
1
Patient-Device Incompatibility
1
1
Material Twisted/Bent
1
1
Mechanical Problem
1
1
Appropriate Term/Code Not Available
1
1
Patient Device Interaction Problem
1
1
Loosening of Implant Not Related to Bone-Ingrowth
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pain
10
10
Inadequate Pain Relief
10
10
Failure of Implant
5
5
No Known Impact Or Consequence To Patient
5
5
Loss of Range of Motion
4
4
No Code Available
3
3
Skin Infection
3
3
Reaction to Medicinal Component of Device
3
3
Joint Swelling
2
2
Malaise
1
1
Disability
1
1
Osteolysis
1
1
Unspecified Infection
1
1
No Patient Involvement
1
1
Limited Mobility Of The Implanted Joint
1
1
Scar Tissue
1
1
Swelling
1
1
Tissue Damage
1
1
Burning Sensation
1
1
Discomfort
1
1
Debris, Bone Shedding
1
1
Fatigue
1
1
Bone Fracture(s)
1
1
Headache
1
1
Hypersensitivity/Allergic reaction
1
1
Insufficient Information
1
1
No Clinical Signs, Symptoms or Conditions
1
1
No Information
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Arthrosurface, Inc.
II
Dec-23-2015
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