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TPLC
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Device
prosthesis, wrist, 3 part metal-plastic-metal articulation, semi-constrained
Product Code
JWJ
Regulation Number
888.3800
Device Class
2
Premarket Reviews
Manufacturer
Decision
ARTHROSURFACE, INC.
SUBSTANTIALLY EQUIVALENT
1
EXTREMITY MEDICAL, LLC.
SUBSTANTIALLY EQUIVALENT
1
1. K191525
KinematX Total Wrist Arthroplasty System
INTEGRA LIFE SCIENCES CORPORATION
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
11
11
2015
7
7
2016
48
48
2017
37
37
2018
31
31
2019
127
127
2020
34
34
2021
8
8
2022
65
65
2023
26
26
2024
10
10
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
161
161
Insufficient Information
62
62
Migration
28
28
Material Disintegration
21
21
Migration or Expulsion of Device
18
18
Loss of Osseointegration
16
16
Loose or Intermittent Connection
14
14
Break
12
12
Naturally Worn
12
12
Loosening of Implant Not Related to Bone-Ingrowth
12
12
Fracture
8
8
Device Dislodged or Dislocated
7
7
Therapeutic or Diagnostic Output Failure
7
7
Osseointegration Problem
6
6
Appropriate Term/Code Not Available
6
6
Inadequacy of Device Shape and/or Size
6
6
Patient-Device Incompatibility
5
5
Unstable
4
4
Material Erosion
4
4
Loss of or Failure to Bond
4
4
Protective Measures Problem
4
4
Failure To Adhere Or Bond
3
3
Device Slipped
3
3
Compatibility Problem
3
3
Material Integrity Problem
3
3
Device Operates Differently Than Expected
3
3
Failure to Osseointegrate
2
2
Biocompatibility
2
2
Delamination
2
2
Degraded
2
2
Nonstandard Device
1
1
Delivered as Unsterile Product
1
1
Material Separation
1
1
Crack
1
1
Device Expiration Issue
1
1
Material Fragmentation
1
1
Labelling, Instructions for Use or Training Problem
1
1
Device Contamination With Biological Material
1
1
Metal Shedding Debris
1
1
Expiration Date Error
1
1
Device Contaminated During Manufacture or Shipping
1
1
Material Deformation
1
1
Unintended Movement
1
1
Device Handling Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pain
58
58
Failure of Implant
54
54
No Code Available
53
53
Osteolysis
49
49
No Known Impact Or Consequence To Patient
38
38
Unspecified Infection
36
36
Loss of Range of Motion
27
27
No Information
24
24
Synovitis
13
13
Inflammation
12
12
Inadequate Osseointegration
11
11
Patient Problem/Medical Problem
11
11
Swelling
10
10
Implant Pain
9
9
Insufficient Information
8
8
Tissue Damage
8
8
Scar Tissue
8
8
Bone Fracture(s)
8
8
Burning Sensation
7
7
Injury
7
7
Post Operative Wound Infection
7
7
Tingling
6
6
Nerve Damage
6
6
Arthralgia
5
5
Joint Dislocation
4
4
No Patient Involvement
4
4
No Clinical Signs, Symptoms or Conditions
4
4
Discomfort
3
3
Osteopenia/ Osteoporosis
3
3
Limited Mobility Of The Implanted Joint
3
3
Weakness
3
3
Foreign Body Reaction
3
3
Hypersensitivity/Allergic reaction
3
3
Wound Dehiscence
3
3
Capsular Contracture
3
3
Cyst(s)
2
2
Ossification
2
2
Bacterial Infection
2
2
Erosion
2
2
Skin Irritation
2
2
Rash
2
2
Reaction
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Swelling/ Edema
2
2
Test Result
1
1
Numbness
1
1
Collapse
1
1
Joint Laxity
1
1
Malunion of Bone
1
1
Metal Related Pathology
1
1
Solid Tumour
1
1
Muscular Rigidity
1
1
Necrosis
1
1
Pneumothorax
1
1
No Consequences Or Impact To Patient
1
1
Rupture
1
1
Hematoma
1
1
Infiltration into Tissue
1
1
Adhesion(s)
1
1
Arthritis
1
1
Erythema
1
1
Fall
1
1
Fever
1
1
Fistula
1
1
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