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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
63
63
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
395
430
Loosening of Implant Not Related to Bone-Ingrowth
139
164
Appropriate Term/Code Not Available
118
118
Fracture
81
81
Loose or Intermittent Connection
62
62
Naturally Worn
48
48
Insufficient Information
41
41
Device Dislodged or Dislocated
39
39
Unstable
30
30
Detachment of Device or Device Component
26
26
Migration
16
16
Break
13
13
Material Erosion
10
10
Patient Device Interaction Problem
9
9
Malposition of Device
7
7
Difficult to Insert
7
7
Loss of Osseointegration
6
6
Migration or Expulsion of Device
4
4
Loss of or Failure to Bond
4
4
Use of Device Problem
4
4
Osseointegration Problem
3
3
Unintended Movement
3
3
Improper or Incorrect Procedure or Method
3
3
Inadequacy of Device Shape and/or Size
3
3
Noise, Audible
2
2
Mechanical Jam
2
2
No Apparent Adverse Event
2
2
Material Protrusion/Extrusion
2
2
Tear, Rip or Hole in Device Packaging
2
2
Packaging Problem
2
2
Positioning Failure
2
2
Degraded
2
2
Manufacturing, Packaging or Shipping Problem
2
2
Peeled/Delaminated
2
2
Expulsion
2
2
Device Slipped
2
2
Misconnection
1
1
Component Missing
1
1
Material Separation
1
1
Material Fragmentation
1
1
Positioning Problem
1
1
Material Integrity Problem
1
1
Difficult to Open or Close
1
1
Patient-Device Incompatibility
1
1
Device Markings/Labelling Problem
1
1
Deformation Due to Compressive Stress
1
1
Off-Label Use
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Failure of Implant
184
189
Unspecified Infection
160
200
Insufficient Information
144
144
Joint Laxity
136
136
Pain
100
100
Bone Fracture(s)
79
79
Loss of Range of Motion
41
41
Joint Dislocation
33
33
No Clinical Signs, Symptoms or Conditions
33
33
Fall
20
20
Implant Pain
18
18
Swelling/ Edema
14
14
No Code Available
14
14
No Information
14
14
Peripheral Nervous Injury
13
33
Osteolysis
13
13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
12
12
No Known Impact Or Consequence To Patient
12
12
Ossification
11
11
Osteopenia/ Osteoporosis
11
11
Metal Related Pathology
10
10
Muscle/Tendon Damage
9
9
Limb Fracture
9
9
Numbness
9
9
Injury
9
9
Impaired Healing
9
9
Bacterial Infection
8
8
Scar Tissue
8
8
Inadequate Osseointegration
8
8
Wound Dehiscence
7
7
Adhesion(s)
7
7
Nerve Damage
7
7
Reaction
6
6
Hematoma
6
6
Tissue Breakdown
5
5
Malunion of Bone
5
5
Limited Mobility Of The Implanted Joint
5
5
Inflammation
5
5
Post Operative Wound Infection
5
5
Muscle Weakness
5
5
Cramp(s) /Muscle Spasm(s)
5
5
Synovitis
5
5
Hypersensitivity/Allergic reaction
4
4
Patient Problem/Medical Problem
4
4
Tissue Damage
4
4
No Consequences Or Impact To Patient
4
4
Nodule
3
3
Fracture, Arm
3
3
Arthritis
3
3
Foreign Body In Patient
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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