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TPLC
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show TPLC since
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Device
prosthesis, hip, femoral, resurfacing
Product Code
KXA
Regulation Number
888.3400
Device Class
2
Premarket Reviews
Manufacturer
Decision
BIOCORE9 LLC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
430
430
2019
971
971
2020
373
373
2021
17
17
2022
13
13
2023
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
690
690
Insufficient Information
228
228
Device Dislodged or Dislocated
207
207
Migration
153
153
Naturally Worn
141
141
Loss of Osseointegration
123
123
Appropriate Term/Code Not Available
88
88
Corroded
76
76
Fracture
54
54
Loss of or Failure to Bond
45
45
Osseointegration Problem
45
45
Degraded
44
44
Noise, Audible
39
39
Biocompatibility
26
26
Use of Device Problem
24
24
Nonstandard Device
23
23
Loose or Intermittent Connection
18
18
Material Erosion
18
18
Malposition of Device
17
17
Unintended Movement
17
17
Inadequacy of Device Shape and/or Size
13
13
Break
12
12
Material Disintegration
11
11
Metal Shedding Debris
10
10
Failure to Osseointegrate
6
6
Loosening of Implant Not Related to Bone-Ingrowth
6
6
Off-Label Use
4
4
Patient-Device Incompatibility
3
3
Migration or Expulsion of Device
3
3
Device-Device Incompatibility
2
2
Expiration Date Error
2
2
Particulates
2
2
Entrapment of Device
2
2
Physical Resistance/Sticking
2
2
No Apparent Adverse Event
2
2
Material Integrity Problem
2
2
Output Problem
2
2
Packaging Problem
2
2
Illegible Information
2
2
Scratched Material
1
1
Mechanical Jam
1
1
Difficult or Delayed Separation
1
1
Patient Device Interaction Problem
1
1
Device Expiration Issue
1
1
Material Separation
1
1
Incorrect Measurement
1
1
Mechanical Problem
1
1
Difficult to Insert
1
1
Unstable
1
1
Microbial Contamination of Device
1
1
Incomplete or Missing Packaging
1
1
Tear, Rip or Hole in Device Packaging
1
1
Device Contamination with Chemical or Other Material
1
1
Device Contaminated During Manufacture or Shipping
1
1
Activation, Positioning or Separation Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Code Available
1097
1097
Pain
843
843
Foreign Body Reaction
281
281
Test Result
259
259
Unspecified Infection
256
256
Joint Dislocation
205
205
Not Applicable
174
174
Tissue Damage
163
163
Bone Fracture(s)
150
150
No Consequences Or Impact To Patient
144
144
Osteolysis
133
133
Inadequate Osseointegration
123
123
Hypersensitivity/Allergic reaction
112
112
Injury
97
97
Limited Mobility Of The Implanted Joint
80
80
No Patient Involvement
68
68
Reaction
51
51
Discomfort
47
47
Thrombosis
45
45
Edema
39
39
Loss of Range of Motion
38
38
Inflammation
35
35
Pulmonary Embolism
31
31
No Information
25
25
Metal Related Pathology
24
24
Necrosis
23
23
Adhesion(s)
21
21
Hematoma
20
20
Weakness
17
17
Host-Tissue Reaction
16
16
Ossification
16
16
Sepsis
15
15
Hemorrhage/Bleeding
14
14
Toxicity
14
14
Swelling
13
13
Fatigue
12
12
Ambulation Difficulties
12
12
Distress
11
11
Cyst(s)
11
11
Myocardial Infarction
11
11
Nerve Damage
10
10
Joint Disorder
10
10
Anxiety
9
9
Stroke/CVA
9
9
Death
8
8
Pocket Erosion
8
8
No Known Impact Or Consequence To Patient
8
8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
8
8
Memory Loss/Impairment
7
7
Muscular Rigidity
6
6
Pneumonia
6
6
Failure of Implant
6
6
Neuropathy
6
6
Synovitis
6
6
Fall
6
6
Post Operative Wound Infection
6
6
Hip Fracture
5
5
Hypoesthesia
5
5
Deformity/ Disfigurement
5
5
Insufficient Information
5
5
Local Reaction
5
5
Renal Failure
5
5
Tinnitus
4
4
Hearing Impairment
4
4
Wound Dehiscence
4
4
Depression
4
4
Heart Failure
3
3
Respiratory Failure
3
3
Fibrosis
3
3
Osteopenia/ Osteoporosis
3
3
Unspecified Tissue Injury
3
3
Swelling/ Edema
3
3
Erosion
3
3
Urinary Retention
3
3
Skin Irritation
3
3
Scarring
3
3
Tachycardia
2
2
Scar Tissue
2
2
Rash
2
2
Neurological Deficit/Dysfunction
2
2
Cardiac Arrest
2
2
Arthritis
2
2
Dyspnea
2
2
Hair Loss
2
2
No Clinical Signs, Symptoms or Conditions
2
2
Thromboembolism
2
2
Foreign Body In Patient
2
2
Irritability
2
2
Pressure Sores
2
2
Impaired Healing
2
2
Numbness
1
1
Respiratory Tract Infection
1
1
Arthralgia
1
1
Shaking/Tremors
1
1
Confusion/ Disorientation
1
1
Blood Loss
1
1
Weight Changes
1
1
Decreased Sensitivity
1
1
Fluid Discharge
1
1
Muscle/Tendon Damage
1
1
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