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TPLC
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Device
prosthesis, elbow, constrained, cemented
Regulation Description
Elbow joint metal/polymer constrained cemented prosthesis.
Product Code
JDC
Regulation Number
888.3150
Device Class
2
MDR Year
MDR Reports
MDR Events
2020
179
179
2021
157
157
2022
130
130
2023
190
190
2024
176
216
2025
17
17
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
369
404
Loosening of Implant Not Related to Bone-Ingrowth
130
155
Appropriate Term/Code Not Available
118
118
Fracture
78
78
Loose or Intermittent Connection
62
62
Naturally Worn
48
48
Insufficient Information
37
37
Device Dislodged or Dislocated
36
36
Unstable
29
29
Detachment of Device or Device Component
26
26
Migration
14
14
Break
13
13
Patient Device Interaction Problem
8
8
Material Erosion
8
8
Difficult to Insert
7
7
Malposition of Device
7
7
Loss of Osseointegration
6
6
Loss of or Failure to Bond
4
4
Migration or Expulsion of Device
4
4
Use of Device Problem
4
4
Inadequacy of Device Shape and/or Size
3
3
Osseointegration Problem
3
3
Unintended Movement
3
3
Improper or Incorrect Procedure or Method
3
3
Manufacturing, Packaging or Shipping Problem
2
2
Mechanical Jam
2
2
Degraded
2
2
Peeled/Delaminated
2
2
No Apparent Adverse Event
2
2
Expulsion
2
2
Noise, Audible
2
2
Tear, Rip or Hole in Device Packaging
2
2
Device Slipped
2
2
Material Protrusion/Extrusion
2
2
Packaging Problem
2
2
Positioning Failure
2
2
Positioning Problem
1
1
Material Integrity Problem
1
1
Deformation Due to Compressive Stress
1
1
Material Separation
1
1
Device Markings/Labelling Problem
1
1
Misconnection
1
1
Difficult to Open or Close
1
1
Material Fragmentation
1
1
Component Missing
1
1
Off-Label Use
1
1
Patient-Device Incompatibility
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Failure of Implant
168
173
Unspecified Infection
153
193
Insufficient Information
137
137
Joint Laxity
126
126
Pain
94
94
Bone Fracture(s)
77
77
Loss of Range of Motion
37
37
No Clinical Signs, Symptoms or Conditions
32
32
Joint Dislocation
30
30
Fall
20
20
Implant Pain
18
18
No Information
14
14
No Code Available
14
14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
12
12
No Known Impact Or Consequence To Patient
12
12
Osteopenia/ Osteoporosis
11
11
Peripheral Nervous Injury
11
31
Injury
9
9
Osteolysis
9
9
Metal Related Pathology
9
9
Limb Fracture
9
9
Inadequate Osseointegration
8
8
Ossification
8
8
Nerve Damage
7
7
Swelling/ Edema
7
7
Wound Dehiscence
7
7
Reaction
6
6
Numbness
6
6
Synovitis
5
5
Scar Tissue
5
5
Malunion of Bone
5
5
Cramp(s) /Muscle Spasm(s)
5
5
Inflammation
5
5
Adhesion(s)
5
5
Tissue Breakdown
5
5
Limited Mobility Of The Implanted Joint
5
5
Post Operative Wound Infection
5
5
Hypersensitivity/Allergic reaction
4
4
Patient Problem/Medical Problem
4
4
Muscle/Tendon Damage
4
4
Impaired Healing
4
4
Tissue Damage
4
4
No Consequences Or Impact To Patient
4
4
Bacterial Infection
3
3
Arthritis
3
3
Nodule
3
3
Muscle Weakness
3
3
Fracture, Arm
3
3
Rheumatoid Arthritis
2
2
Joint Contracture
2
2
Recalls
Manufacturer
Recall Class
Date Posted
1
Limacorporate S.p.A
II
Mar-16-2023
2
Zimmer Biomet, Inc.
II
Feb-05-2020
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