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TPLC
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Device
prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
Product Code
KWY
Regulation Number
888.3390
Device Class
2
Premarket Reviews
Manufacturer
Decision
CORIN USA LIMITED
SUBSTANTIALLY EQUIVALENT
1
DEPUY IRELAND UC
SUBSTANTIALLY EQUIVALENT
1
G21, S.R.L.
SUBSTANTIALLY EQUIVALENT
1
HERAEUS MEDICAL GMBH
SUBSTANTIALLY EQUIVALENT
2
IMPLANTCAST, GMBH
SUBSTANTIALLY EQUIVALENT
1
KYOCERA MEDICAL TECHNOLOGIES, INC.
SUBSTANTIALLY EQUIVALENT
1
THEKEN COMPANIES, LLC
SUBSTANTIALLY EQUIVALENT
1
WALDEMAR LINK GMBH & CO. KG
SUBSTANTIALLY EQUIVALENT
1
ZIMMER GMBH
SUBSTANTIALLY EQUIVALENT
1
1. K192236
Fitmore Hip Stem
MDR Year
MDR Reports
MDR Events
2019
1530
1530
2020
1260
1260
2021
276
276
2022
208
208
2023
177
177
2024
68
68
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
1545
1545
Device Dislodged or Dislocated
797
797
Naturally Worn
397
397
Fracture
176
176
Insufficient Information
105
105
Difficult to Insert
85
85
Loss of Osseointegration
80
80
Migration
76
76
Noise, Audible
62
62
Appropriate Term/Code Not Available
60
60
Corroded
59
59
Loosening of Implant Not Related to Bone-Ingrowth
43
43
Material Erosion
42
42
Loss of or Failure to Bond
41
41
Biocompatibility
34
34
Detachment of Device or Device Component
33
33
Nonstandard Device
32
32
Degraded
30
30
Osseointegration Problem
28
28
Break
25
25
Use of Device Problem
25
25
Unintended Movement
23
23
Malposition of Device
22
22
Device Contaminated During Manufacture or Shipping
21
21
Delivered as Unsterile Product
20
20
Patient Device Interaction Problem
17
17
Unstable
14
14
Packaging Problem
11
11
Positioning Failure
11
11
Device-Device Incompatibility
10
10
Separation Failure
8
8
Off-Label Use
8
8
Difficult to Remove
7
7
Failure to Osseointegrate
7
7
Fitting Problem
7
7
Mechanical Problem
7
7
No Apparent Adverse Event
7
7
Loose or Intermittent Connection
6
6
Inadequacy of Device Shape and/or Size
5
5
Patient-Device Incompatibility
5
5
Mechanical Jam
4
4
Positioning Problem
4
4
Scratched Material
4
4
Device Damaged Prior to Use
4
4
Crack
4
4
Expiration Date Error
3
3
Tear, Rip or Hole in Device Packaging
3
3
Manufacturing, Packaging or Shipping Problem
3
3
Contamination /Decontamination Problem
3
3
Activation, Positioning or Separation Problem
3
3
Physical Resistance/Sticking
3
3
Device Markings/Labelling Problem
2
2
Device Contamination with Chemical or Other Material
2
2
Deformation Due to Compressive Stress
2
2
Material Integrity Problem
2
2
Material Twisted/Bent
2
2
Material Separation
2
2
Material Disintegration
2
2
Difficult or Delayed Positioning
2
2
Migration or Expulsion of Device
2
2
Misassembled
1
1
Pitted
1
1
Incorrect Measurement
1
1
Contamination
1
1
Shipping Damage or Problem
1
1
Material Too Rigid or Stiff
1
1
Device Appears to Trigger Rejection
1
1
Dull, Blunt
1
1
Incomplete or Missing Packaging
1
1
Solder Joint Fracture
1
1
Material Deformation
1
1
No Fail-Safe Mechanism
1
1
Misassembly by Users
1
1
Connection Problem
1
1
Defective Device
1
1
Human-Device Interface Problem
1
1
Compatibility Problem
1
1
Installation-Related Problem
1
1
Activation Problem
1
1
Inaccurate Information
1
1
Unclear Information
1
1
Component Misassembled
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Code Available
1995
1998
Pain
1082
1083
Joint Dislocation
716
717
Unspecified Infection
611
612
Test Result
421
421
Foreign Body Reaction
351
351
Osteolysis
217
217
Injury
169
169
Bone Fracture(s)
159
159
Tissue Damage
156
156
Hypersensitivity/Allergic reaction
153
153
No Clinical Signs, Symptoms or Conditions
126
126
Limited Mobility Of The Implanted Joint
124
124
Inadequate Osseointegration
111
111
Discomfort
109
109
Insufficient Information
105
105
Failure of Implant
101
101
Loss of Range of Motion
90
90
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
77
77
No Consequences Or Impact To Patient
76
76
Inflammation
74
74
No Information
68
68
Edema
67
67
Hematoma
61
61
Fall
60
60
Necrosis
60
60
Not Applicable
60
60
Thrombosis
60
60
Joint Laxity
50
50
No Known Impact Or Consequence To Patient
47
47
Pulmonary Embolism
45
45
No Patient Involvement
43
43
Ambulation Difficulties
42
42
Adhesion(s)
37
37
Weakness
32
32
Metal Related Pathology
30
30
Ossification
30
30
Fatigue
27
27
Scar Tissue
27
27
Cyst(s)
26
26
Hemorrhage/Bleeding
25
25
Reaction
21
21
Swelling
20
20
Nerve Damage
19
19
Hip Fracture
17
17
Unspecified Tissue Injury
16
16
Impaired Healing
15
15
Joint Disorder
15
15
Anxiety
15
15
Local Reaction
15
15
Fever
14
14
Death
14
14
Osteopenia/ Osteoporosis
14
14
Swelling/ Edema
12
12
Depression
11
11
Wound Dehiscence
11
11
Host-Tissue Reaction
11
11
Dyspnea
10
10
Distress
10
10
Synovitis
9
9
Deformity/ Disfigurement
9
9
Sepsis
9
9
Stroke/CVA
8
8
Post Operative Wound Infection
8
8
Physical Asymmetry
8
8
Patient Problem/Medical Problem
8
8
Fibrosis
8
8
Implant Pain
7
7
Muscle/Tendon Damage
7
7
Arthralgia
7
7
Pocket Erosion
7
7
Myocardial Infarction
7
7
Skin Irritation
6
6
Hearing Impairment
6
6
Toxicity
6
6
Sleep Dysfunction
6
6
Tachycardia
5
5
Tinnitus
5
5
Fluid Discharge
5
5
Blood Loss
5
5
Erosion
5
5
Calcium Deposits/Calcification
5
5
Seroma
5
5
Muscular Rigidity
5
5
Neurological Deficit/Dysfunction
5
5
Memory Loss/Impairment
4
4
Renal Failure
4
4
Rash
4
4
Cardiac Arrest
4
4
Abscess
4
4
Foreign Body In Patient
4
4
Thromboembolism
3
3
Thrombosis/Thrombus
3
3
Limb Fracture
3
3
Burning Sensation
3
3
Heart Failure
3
3
Numbness
3
3
Hypoesthesia
3
3
Non-union Bone Fracture
3
3
Arthritis
3
3
Recalls
Manufacturer
Recall Class
Date Posted
1
Biomet, Inc.
II
Apr-03-2020
2
Zimmer Biomet, Inc.
II
Nov-22-2019
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