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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
CORIN USA
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
2438
2438
2015
1684
1684
2016
625
625
2017
580
580
2018
430
430
2019
971
971
2020
373
373
2021
17
17
2022
13
13
2023
6
6
2024
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Insufficient Information
4091
4091
Adverse Event Without Identified Device or Use Problem
902
902
Appropriate Term/Code Not Available
549
549
Device Dislodged or Dislocated
411
411
Loss of Osseointegration
404
404
Noise, Audible
335
335
Metal Shedding Debris
256
256
Naturally Worn
205
205
Migration
153
153
Corroded
152
152
Fracture
99
99
Loss of or Failure to Bond
71
71
Malposition of Device
56
56
Osseointegration Problem
53
53
Degraded
52
52
Nonstandard Device
45
45
Loose or Intermittent Connection
45
45
Use of Device Problem
27
27
Biocompatibility
26
26
Migration or Expulsion of Device
26
26
Device Slipped
24
24
Material Erosion
23
23
Break
21
21
Unintended Movement
17
17
Material Disintegration
17
17
Inadequacy of Device Shape and/or Size
14
14
Patient-Device Incompatibility
12
12
Device Operates Differently Than Expected
11
11
Failure to Osseointegrate
9
9
Mechanical Problem
6
6
Loosening of Implant Not Related to Bone-Ingrowth
6
6
Unstable
6
6
Off-Label Use
4
4
Product Quality Problem
4
4
Patient Device Interaction Problem
4
4
Disassembly
3
3
Material Integrity Problem
3
3
Particulates
3
3
Device Issue
3
3
Physical Resistance/Sticking
2
2
Entrapment of Device
2
2
Detachment Of Device Component
2
2
Output Problem
2
2
Connection Problem
2
2
Device-Device Incompatibility
2
2
Expiration Date Error
2
2
Illegible Information
2
2
Material Separation
2
2
Failure To Adhere Or Bond
2
2
Difficult to Insert
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pain
3926
3926
No Code Available
2357
2357
Host-Tissue Reaction
1440
1440
No Information
1200
1200
Foreign Body Reaction
779
779
Tissue Damage
477
477
Unspecified Infection
353
353
Osteolysis
347
347
Discomfort
318
318
Test Result
282
282
Bone Fracture(s)
257
257
Joint Dislocation
234
234
Not Applicable
228
228
Injury
156
156
No Consequences Or Impact To Patient
150
150
Inflammation
141
141
Inadequate Osseointegration
139
139
Limited Mobility Of The Implanted Joint
136
136
Reaction
135
135
Hypersensitivity/Allergic reaction
121
121
Necrosis
81
81
Loss of Range of Motion
76
76
Ambulation Difficulties
74
74
Toxicity
69
69
No Patient Involvement
68
68
Weakness
58
58
Muscle Weakness
57
57
Edema
55
55
Swelling
53
53
Thrombosis
46
46
Joint Swelling
35
35
Pulmonary Embolism
34
34
Failure of Implant
34
34
Cyst(s)
33
33
Death
30
30
Synovitis
28
28
Metal Related Pathology
27
27
Adhesion(s)
25
25
No Known Impact Or Consequence To Patient
24
24
Ossification
21
21
Hematoma
20
20
Joint Disorder
18
18
Fall
18
18
Fatigue
16
16
Hip Fracture
16
16
Distress
16
16
Deformity/ Disfigurement
15
15
Sepsis
15
15
Hemorrhage/Bleeding
15
15
Anxiety
15
15
Recalls
Manufacturer
Recall Class
Date Posted
1
Depuy Orthopaedics, Inc.
II
Mar-24-2011
2
Zimmer, Inc.
II
Nov-06-2012
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