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TPLC
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Device
prosthesis, hip, hemi-, trunnion-bearing, femoral, metal/polyacetal
Product Code
JDH
Regulation Number
888.3380
Device Class
3
MDR Year
MDR Reports
MDR Events
2014
323
323
2015
122
122
2016
94
94
2017
82
82
2018
223
223
2019
354
354
2020
292
292
2021
158
158
2022
76
76
2023
5
5
Device Problems
MDRs with this Device Problem
Events in those MDRs
Insufficient Information
521
521
Adverse Event Without Identified Device or Use Problem
323
323
Device Dislodged or Dislocated
205
205
Fracture
119
119
Break
101
101
Appropriate Term/Code Not Available
77
77
Loose or Intermittent Connection
67
67
Naturally Worn
52
52
Loosening of Implant Not Related to Bone-Ingrowth
49
49
Device Slipped
28
28
Unintended Movement
22
22
Biocompatibility
20
20
Migration or Expulsion of Device
19
19
Unstable
18
18
Corroded
17
17
Device Operates Differently Than Expected
15
15
Degraded
11
11
Detachment Of Device Component
9
9
Material Deformation
9
9
Positioning Problem
9
9
Noise, Audible
9
9
Patient Device Interaction Problem
8
8
Material Integrity Problem
8
8
Compatibility Problem
8
8
Loss of Osseointegration
8
8
Metal Shedding Debris
7
7
Failure To Adhere Or Bond
6
6
Crack
5
5
Material Separation
5
5
Malposition of Device
5
5
Connection Problem
4
4
Migration
4
4
Inadequacy of Device Shape and/or Size
4
4
Fitting Problem
4
4
Material Erosion
4
4
Difficult to Insert
4
4
Mechanical Problem
3
3
Misassembled
3
3
Nonstandard Device
3
3
Pitted
3
3
Difficult To Position
3
3
Incomplete or Inadequate Connection
3
3
Activation, Positioning or Separation Problem
3
3
Device Damaged by Another Device
3
3
Patient-Device Incompatibility
3
3
Mechanical Jam
3
3
Separation Failure
2
2
Contamination /Decontamination Problem
2
2
Osseointegration Problem
2
2
Off-Label Use
2
2
Material Rupture
1
1
Component Missing
1
1
Dull, Blunt
1
1
Cut In Material
1
1
Failure to Osseointegrate
1
1
Improper or Incorrect Procedure or Method
1
1
Use of Device Problem
1
1
Accessory Incompatible
1
1
Material Fragmentation
1
1
Device Expiration Issue
1
1
Positioning Failure
1
1
Disconnection
1
1
Contamination
1
1
Failure to Convert to Back-Up
1
1
Loss of or Failure to Bond
1
1
Collapse
1
1
Device Handling Problem
1
1
Illegible Information
1
1
Unclear Information
1
1
Physical Resistance/Sticking
1
1
Device-Device Incompatibility
1
1
Detachment of Device or Device Component
1
1
Device Contamination with Chemical or Other Material
1
1
Material Twisted/Bent
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Injury
528
528
No Code Available
369
369
Unspecified Infection
170
170
Pain
137
137
Joint Dislocation
124
124
No Clinical Signs, Symptoms or Conditions
95
95
Bone Fracture(s)
88
88
Failure of Implant
83
83
No Information
75
75
No Known Impact Or Consequence To Patient
47
47
Metal Related Pathology
41
41
No Consequences Or Impact To Patient
32
32
Osteolysis
26
26
Hip Fracture
19
19
Inadequate Osseointegration
14
14
Loss of Range of Motion
11
11
Fall
10
10
Thrombosis/Thrombus
10
10
Insufficient Information
10
10
Test Result
9
9
Ambulation Difficulties
9
9
Necrosis
8
8
Inflammation
7
7
Discomfort
6
6
Toxicity
5
5
Implant Pain
5
5
Swelling/ Edema
4
4
Subluxation
4
4
Joint Laxity
4
4
Complaint, Ill-Defined
4
4
Swelling
3
3
Thrombosis
3
3
Hematoma
3
3
Ossification
3
3
Bacterial Infection
3
3
Unequal Limb Length
3
3
Foreign Body In Patient
3
3
Neuralgia
3
3
Non-union Bone Fracture
3
3
Joint Disorder
3
3
Post Operative Wound Infection
3
3
Tissue Breakdown
2
2
Reaction
2
2
Cyst(s)
2
2
Death
2
2
Hemorrhage/Bleeding
2
2
Muscular Rigidity
2
2
Infiltration into Tissue
2
2
Scar Tissue
2
2
Arthralgia
2
2
Deformity/ Disfigurement
1
1
Hernia
1
1
Wheal(s)
1
1
Sepsis
1
1
Staphylococcus Aureus
1
1
Tissue Damage
1
1
Ventricular Fibrillation
1
1
Synovitis
1
1
Tachycardia
1
1
Fistula
1
1
Foreign Body Sensation in Eye
1
1
Laceration(s)
1
1
Muscle Weakness
1
1
Hypersensitivity/Allergic reaction
1
1
Debris, Bone Shedding
1
1
Chest Pain
1
1
Impaired Healing
1
1
Disability
1
1
No Patient Involvement
1
1
Osteopenia/ Osteoporosis
1
1
Thromboembolism
1
1
Limited Mobility Of The Implanted Joint
1
1
Cardiovascular Insufficiency
1
1
Unspecified Heart Problem
1
1
Device Embedded In Tissue or Plaque
1
1
Unspecified Musculoskeletal problem
1
1
Skin Infection
1
1
Muscle/Tendon Damage
1
1
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