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TPLC
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show TPLC since
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Device
prosthesis, elbow, semi-constrained, cemented
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
2019
30
30
2020
32
32
2021
23
23
2022
60
83
2023
30
30
2024
57
57
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
97
102
Loosening of Implant Not Related to Bone-Ingrowth
38
38
Device Dislodged or Dislocated
17
35
Osseointegration Problem
15
23
Unstable
14
23
Insufficient Information
13
13
Fracture
11
11
Loss of Osseointegration
7
7
Patient Device Interaction Problem
6
6
Naturally Worn
6
6
Break
6
6
Appropriate Term/Code Not Available
6
6
Use of Device Problem
4
4
Detachment of Device or Device Component
4
4
Unintended Movement
3
3
Migration
3
3
Loss of or Failure to Bond
3
3
Inaccurate Information
2
2
Malposition of Device
2
2
Migration or Expulsion of Device
2
2
Device Slipped
1
1
Material Erosion
1
1
Therapeutic or Diagnostic Output Failure
1
1
Material Integrity Problem
1
1
Degraded
1
1
Improper or Incorrect Procedure or Method
1
1
Mechanical Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Unspecified Infection
43
47
Implant Pain
30
30
Insufficient Information
27
45
Failure of Implant
26
26
Joint Laxity
22
31
Loss of Range of Motion
22
22
Pain
20
20
Inadequate Osseointegration
16
24
No Information
15
15
Bone Fracture(s)
12
12
No Code Available
9
9
Swelling/ Edema
9
9
No Clinical Signs, Symptoms or Conditions
8
8
Discomfort
8
8
Joint Dislocation
7
7
Injury
7
7
Bacterial Infection
4
4
No Known Impact Or Consequence To Patient
4
4
Ossification
4
4
Fluid Discharge
4
4
Post Operative Wound Infection
4
4
Tissue Damage
3
3
Skin Inflammation/ Irritation
3
3
Inflammation
3
3
Osteolysis
3
3
No Consequences Or Impact To Patient
2
2
Limb Fracture
2
2
Reaction
2
2
Foreign Body In Patient
2
2
Post Traumatic Wound Infection
2
2
Cyst(s)
2
2
Neuropathy
2
2
Scar Tissue
1
1
Fall
1
1
Foreign Body Reaction
1
1
Adhesion(s)
1
1
Rheumatoid Arthritis
1
1
Unspecified Tissue Injury
1
1
Wound Dehiscence
1
1
Impaired Healing
1
1
Erosion
1
1
Device Embedded In Tissue or Plaque
1
1
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