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TPLC
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show TPLC since
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Device
prosthesis, hip, semi-constrained, metal/polymer, uncemented
Product Code
LWJ
Regulation Number
888.3360
Device Class
2
MDR Year
MDR Reports
MDR Events
2019
211
211
2020
189
189
2021
155
155
2022
91
91
2023
72
72
2024
44
44
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
141
141
Adverse Event Without Identified Device or Use Problem
140
140
Insufficient Information
109
109
Device Dislodged or Dislocated
91
91
Fracture
58
58
Loose or Intermittent Connection
47
47
Loss of Osseointegration
28
28
Osseointegration Problem
26
26
Corroded
25
25
Detachment of Device or Device Component
13
13
Appropriate Term/Code Not Available
12
12
Mechanical Problem
11
11
Migration
11
11
Material Integrity Problem
10
10
Compatibility Problem
8
8
Naturally Worn
8
8
Difficult to Remove
8
8
Degraded
8
8
No Apparent Adverse Event
7
7
Material Fragmentation
7
7
Patient Device Interaction Problem
7
7
Use of Device Problem
6
6
Loosening of Implant Not Related to Bone-Ingrowth
6
6
Biocompatibility
5
5
Mechanical Jam
5
5
Device Appears to Trigger Rejection
4
4
Physical Resistance/Sticking
4
4
Noise, Audible
3
3
Tear, Rip or Hole in Device Packaging
3
3
Packaging Problem
3
3
Failure to Osseointegrate
3
3
Device Difficult to Setup or Prepare
3
3
Patient-Device Incompatibility
3
3
Material Disintegration
3
3
Malposition of Device
3
3
Migration or Expulsion of Device
3
3
Unstable
3
3
Scratched Material
2
2
Delivered as Unsterile Product
2
2
Inadequacy of Device Shape and/or Size
2
2
Device Fell
2
2
Entrapment of Device
2
2
Difficult to Insert
1
1
Positioning Failure
1
1
Material Discolored
1
1
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Positioning Problem
1
1
Problem with Sterilization
1
1
Measurement System Incompatibility
1
1
Defective Device
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Information
185
185
Pain
91
91
Insufficient Information
84
84
Unspecified Infection
66
66
Bone Fracture(s)
60
60
Failure of Implant
58
58
No Clinical Signs, Symptoms or Conditions
57
57
No Code Available
39
39
Inadequate Osseointegration
34
34
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
27
27
Joint Dislocation
24
24
Metal Related Pathology
22
22
Injury
17
17
Patient Problem/Medical Problem
15
15
Foreign Body Reaction
15
15
Loss of Range of Motion
14
14
Osteolysis
13
13
Fall
13
13
Joint Laxity
12
12
No Known Impact Or Consequence To Patient
11
11
Limb Fracture
11
11
Hypersensitivity/Allergic reaction
9
9
Hip Fracture
9
9
Joint Disorder
9
9
Foreign Body In Patient
7
7
Discomfort
7
7
Unequal Limb Length
7
7
Inflammation
6
6
Reaction
6
6
Necrosis
5
5
Bacterial Infection
5
5
Ambulation Difficulties
5
5
Unspecified Tissue Injury
4
4
Test Result
4
4
Swelling/ Edema
4
4
No Consequences Or Impact To Patient
4
4
Death
4
4
Wound Dehiscence
4
4
Synovitis
3
3
Tissue Damage
3
3
Fatigue
3
3
Ossification
3
3
Swelling
3
3
Shaking/Tremors
2
2
Toxicity
2
2
Subluxation
2
2
Dyspnea
2
2
Hemorrhage/Bleeding
2
2
Fibrosis
2
2
Distress
2
2
Recalls
Manufacturer
Recall Class
Date Posted
1
Howmedica Osteonics Corp.
II
Jan-31-2024
2
MicroPort Orthopedics Inc.
I
Sep-18-2020
3
MicroPort Orthopedics Inc.
II
Sep-09-2020
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