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TPLC
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show TPLC since
2008
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2018
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2023
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Device
prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Product Code
MRA
Device Class
3
Premarket Approvals (PMA)
2018
2019
2020
2021
2022
2023
11
17
13
18
33
13
MDR Year
MDR Reports
MDR Events
2018
696
696
2019
641
641
2020
371
371
2021
110
110
2022
89
89
2023
93
93
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
1017
1017
Adverse Event Without Identified Device or Use Problem
213
213
Fracture
202
202
Insufficient Information
129
129
Device Dislodged or Dislocated
69
69
Material Twisted/Bent
57
57
Noise, Audible
55
55
Naturally Worn
50
50
Appropriate Term/Code Not Available
41
41
Material Deformation
39
39
Crack
37
37
Osseointegration Problem
29
29
Loosening of Implant Not Related to Bone-Ingrowth
25
25
Scratched Material
23
23
Device-Device Incompatibility
23
23
Loss of Osseointegration
23
23
Loose or Intermittent Connection
18
18
Malposition of Device
15
15
Degraded
14
14
Unstable
14
14
Difficult to Remove
12
12
Use of Device Problem
10
10
Patient Device Interaction Problem
10
10
Connection Problem
9
9
Detachment of Device or Device Component
7
7
Unintended Movement
7
7
Difficult to Insert
7
7
Migration or Expulsion of Device
6
6
Corroded
6
6
Migration
6
6
Physical Resistance/Sticking
6
6
Mechanical Jam
5
5
Biocompatibility
5
5
Loss of or Failure to Bond
5
5
Positioning Failure
5
5
Material Fragmentation
5
5
Inadequacy of Device Shape and/or Size
5
5
Failure to Osseointegrate
5
5
Fitting Problem
5
5
Device Slipped
4
4
Unsealed Device Packaging
4
4
Mechanical Problem
4
4
Material Erosion
4
4
Material Disintegration
3
3
Failure To Adhere Or Bond
3
3
Metal Shedding Debris
3
3
Component Missing
3
3
Patient-Device Incompatibility
3
3
Failure to Disconnect
3
3
Positioning Problem
3
3
Packaging Problem
2
2
Defective Device
2
2
Device Damaged by Another Device
2
2
Device Contaminated During Manufacture or Shipping
2
2
Dull, Blunt
2
2
Device Damaged Prior to Use
2
2
Disassembly
2
2
Material Frayed
2
2
Device Abrasion From Instrument Or Another Object
1
1
Entrapment of Device
1
1
Flaked
1
1
Material Discolored
1
1
Improper or Incorrect Procedure or Method
1
1
Device Issue
1
1
Peeled/Delaminated
1
1
Device Difficult to Setup or Prepare
1
1
Off-Label Use
1
1
Device Appears to Trigger Rejection
1
1
Difficult to Open or Remove Packaging Material
1
1
Device Disinfection Or Sterilization Issue
1
1
Separation Failure
1
1
Failure to Advance
1
1
Ambient Noise Problem
1
1
Contamination /Decontamination Problem
1
1
Material Integrity Problem
1
1
Material Split, Cut or Torn
1
1
Activation Problem
1
1
Separation Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
1064
1064
Pain
254
254
No Code Available
202
202
Not Applicable
134
134
Injury
116
116
Unspecified Infection
93
93
Failure of Implant
58
58
Joint Dislocation
57
57
Insufficient Information
57
57
No Clinical Signs, Symptoms or Conditions
57
57
No Information
52
52
Inadequate Osseointegration
46
46
Metal Related Pathology
41
41
Ambulation Difficulties
31
31
Discomfort
29
29
Foreign Body Reaction
27
27
Bone Fracture(s)
26
26
Tissue Damage
26
26
Inflammation
25
25
Loss of Range of Motion
23
23
No Known Impact Or Consequence To Patient
21
21
Osteolysis
21
21
Test Result
19
19
Limited Mobility Of The Implanted Joint
16
16
Ossification
12
12
Hematoma
11
11
Swelling
11
11
Scar Tissue
11
11
Foreign Body In Patient
11
11
Muscle/Tendon Damage
11
11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
11
11
Swelling/ Edema
10
10
Joint Laxity
10
10
Fall
10
10
Hypersensitivity/Allergic reaction
9
9
Blood Loss
9
9
Reaction
9
9
Adhesion(s)
8
8
Edema
7
7
Cyst(s)
7
7
Joint Disorder
7
7
Weakness
6
6
Synovitis
5
5
No Patient Involvement
5
5
Hip Fracture
5
5
Host-Tissue Reaction
5
5
Necrosis
5
5
Unspecified Tissue Injury
5
5
Thrombosis/Thrombus
5
5
Physical Asymmetry
5
5
Unequal Limb Length
4
4
Nerve Damage
4
4
Muscular Rigidity
4
4
Myocardial Infarction
4
4
Arthralgia
4
4
Post Operative Wound Infection
4
4
Device Embedded In Tissue or Plaque
4
4
Thrombosis
3
3
Fatigue
3
3
Fever
3
3
Infarction, Cerebral
3
3
Abscess
3
3
Bacterial Infection
3
3
Cardiac Arrest
2
2
Death
2
2
Nausea
2
2
Rash
2
2
High Blood Pressure/ Hypertension
2
2
Hemorrhage/Bleeding
2
2
Skin Irritation
2
2
Toxicity
2
2
Chills
2
2
Distress
2
2
Impaired Healing
2
2
Unspecified Musculoskeletal problem
2
2
Nodule
2
2
Implant Pain
2
2
Subluxation
2
2
Malunion of Bone
1
1
Limb Fracture
1
1
Cancer
1
1
Numbness
1
1
Depression
1
1
Hypoesthesia
1
1
Fibrosis
1
1
Burning Sensation
1
1
Anxiety
1
1
Sepsis
1
1
Vomiting
1
1
Hyperplasia
1
1
Headache
1
1
Infiltration into Tissue
1
1
Ecchymosis
1
1
Chest Pain
1
1
Cellulitis
1
1
Erosion
1
1
Calcium Deposits/Calcification
1
1
Anemia
1
1
Arthritis
1
1
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