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TPLC
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Device
prosthesis, elbow, semi-constrained, cemented
Regulation Description
Elbow joint metal/polymer semi-constrained cemented prosthesis.
Product Code
JDB
Regulation Number
888.3160
Device Class
2
Premarket Reviews
Manufacturer
Decision
LIMACORPORATE S.P.A.
SUBSTANTIALLY EQUIVALENT
1
TORNIER INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
32
32
2021
23
23
2022
58
81
2023
30
30
2024
163
163
2025
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
127
132
Osseointegration Problem
58
66
Unstable
33
42
Loosening of Implant Not Related to Bone-Ingrowth
31
31
Fracture
21
21
Device Dislodged or Dislocated
20
38
Break
17
17
Loss of Osseointegration
12
12
Patient Device Interaction Problem
9
9
Insufficient Information
7
7
Naturally Worn
5
5
Migration
4
4
Use of Device Problem
4
4
Detachment of Device or Device Component
4
4
Unintended Movement
3
3
Appropriate Term/Code Not Available
3
3
Inaccurate Information
2
2
Malposition of Device
2
2
Material Integrity Problem
1
1
Mechanical Problem
1
1
Improper or Incorrect Procedure or Method
1
1
Material Erosion
1
1
Degraded
1
1
Loss of or Failure to Bond
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Unspecified Infection
65
69
Inadequate Osseointegration
59
67
Joint Laxity
46
55
Bone Fracture(s)
37
37
Failure of Implant
34
34
Implant Pain
33
33
Insufficient Information
27
45
Loss of Range of Motion
20
20
Pain
13
13
Osteolysis
10
10
Joint Dislocation
10
10
No Clinical Signs, Symptoms or Conditions
9
9
Swelling/ Edema
9
9
Discomfort
9
9
Injury
7
7
No Information
6
6
Fall
5
5
Fluid Discharge
4
4
Post Operative Wound Infection
4
4
Inadequate Pain Relief
4
4
Bacterial Infection
4
4
Skin Inflammation/ Irritation
3
3
Inflammation
3
3
Fever
3
3
Ossification
3
3
Sepsis
3
3
Cyst(s)
2
2
Reaction
2
2
Post Traumatic Wound Infection
2
2
Limb Fracture
2
2
Foreign Body In Patient
2
2
Neuropathy
2
2
Foreign Body Reaction
1
1
Erosion
1
1
Rheumatoid Arthritis
1
1
Adhesion(s)
1
1
Impaired Healing
1
1
Wound Dehiscence
1
1
No Code Available
1
1
Device Embedded In Tissue or Plaque
1
1
Unspecified Tissue Injury
1
1
Tissue Damage
1
1
Scar Tissue
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Limacorporate S.p.A
II
Dec-20-2024
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