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Device
prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
Regulation Description
Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
Product Code
KWY
Regulation Number
888.3390
Device Class
2
Premarket Reviews
Manufacturer
Decision
CORIN USA LIMITED
SUBSTANTIALLY EQUIVALENT
1
KULZER, LLC
SUBSTANTIALLY EQUIVALENT
1
ONKOS SURGICAL
SUBSTANTIALLY EQUIVALENT
1
UNITED ORTHOPEDIC CORPORATION
SUBSTANTIALLY EQUIVALENT
1
ZIMMER GMBH
SUBSTANTIALLY EQUIVALENT
2
ZIMMER, INC.
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2016
884
884
2017
834
834
2018
1395
1395
2019
1534
1534
2020
1289
1289
2021
60
60
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
1627
1627
Insufficient Information
1338
1338
Device Dislodged or Dislocated
1149
1149
Naturally Worn
561
561
Appropriate Term/Code Not Available
483
483
Fracture
188
188
Loss of Osseointegration
146
146
Corroded
139
139
Noise, Audible
116
116
Material Erosion
86
86
Migration
84
84
Difficult to Insert
72
72
Metal Shedding Debris
72
72
Nonstandard Device
55
55
Break
54
54
Migration or Expulsion of Device
48
48
Malposition of Device
47
47
Loss of or Failure to Bond
45
45
Biocompatibility
39
39
Degraded
36
36
Osseointegration Problem
33
33
Disassembly
31
31
Device Contamination with Chemical or Other Material
30
30
Loose or Intermittent Connection
29
29
Use of Device Problem
28
28
Unintended Movement
27
27
Loosening of Implant Not Related to Bone-Ingrowth
26
26
Detachment of Device or Device Component
25
25
Unstable
23
23
Delivered as Unsterile Product
19
19
Device Contaminated During Manufacture or Shipping
17
17
Fitting Problem
17
17
Packaging Problem
14
14
Material Disintegration
14
14
Difficult to Remove
12
12
Device-Device Incompatibility
11
11
Inadequacy of Device Shape and/or Size
10
10
Detachment Of Device Component
10
10
Separation Failure
10
10
Patient-Device Incompatibility
10
10
Difficult To Position
8
8
Mechanical Problem
8
8
No Apparent Adverse Event
7
7
Patient Device Interaction Problem
7
7
Compatibility Problem
7
7
Scratched Material
6
6
Positioning Failure
6
6
Failure to Osseointegrate
6
6
Off-Label Use
5
5
Bent
5
5
Device Operates Differently Than Expected
5
5
Positioning Problem
5
5
Material Deformation
5
5
Device Markings/Labelling Problem
5
5
Contamination /Decontamination Problem
4
4
Device Difficult to Setup or Prepare
4
4
Device Slipped
4
4
Device Expiration Issue
3
3
Defective Device
3
3
Connection Problem
3
3
Tear, Rip or Hole in Device Packaging
3
3
Manufacturing, Packaging or Shipping Problem
3
3
Failure To Adhere Or Bond
3
3
Material Integrity Problem
3
3
Physical Resistance/Sticking
2
2
Device Appears to Trigger Rejection
2
2
Improper or Incorrect Procedure or Method
2
2
Misassembled
2
2
Misconnection
2
2
Difficult or Delayed Positioning
2
2
Material Discolored
2
2
Dull, Blunt
2
2
Device Damaged Prior to Use
2
2
Device Damaged by Another Device
2
2
Device Packaging Compromised
2
2
Material Twisted/Bent
2
2
Mechanical Jam
2
2
Human-Device Interface Problem
2
2
Separation Problem
2
2
Material Separation
2
2
Component Missing
2
2
Expiration Date Error
1
1
Shipping Damage or Problem
1
1
Pitted
1
1
Material Too Rigid or Stiff
1
1
Device Abrasion From Instrument Or Another Object
1
1
Gradient Increase
1
1
Excess Flow or Over-Infusion
1
1
Incorrect Measurement
1
1
Screw
1
1
Heads
1
1
Plate
1
1
Crack
1
1
Inaccurate Information
1
1
Material Split, Cut or Torn
1
1
Installation-Related Problem
1
1
Material Protrusion/Extrusion
1
1
Device Operational Issue
1
1
Delamination
1
1
Activation, Positioning or SeparationProblem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Code Available
2488
2491
Pain
2235
2236
Joint Dislocation
919
920
Unspecified Infection
779
780
No Information
619
619
Test Result
545
545
Foreign Body Reaction
544
544
Injury
461
461
Osteolysis
325
325
Tissue Damage
319
319
Discomfort
308
308
Not Applicable
301
301
Limited Mobility Of The Implanted Joint
227
227
Inflammation
226
226
Host-Tissue Reaction
197
197
Bone Fracture(s)
191
191
Hypersensitivity/Allergic reaction
177
177
No Consequences Or Impact To Patient
171
171
Reaction
170
170
Inadequate Osseointegration
128
128
Loss of Range of Motion
124
124
No Known Impact Or Consequence To Patient
113
113
Ambulation Difficulties
98
98
Edema
89
89
Necrosis
89
89
Hematoma
81
81
Swelling
71
71
Weakness
69
69
Thrombosis
65
65
Distress
55
55
No Patient Involvement
50
50
Pulmonary Embolism
48
48
Fall
46
46
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
43
43
Failure of Implant
41
41
Cyst(s)
40
40
Adhesion(s)
38
38
Impaired Healing
32
32
Fatigue
31
31
Joint Disorder
30
30
Ossification
30
30
Scar Tissue
29
29
Synovitis
28
28
Death
26
26
No Clinical Signs, Symptoms or Conditions
25
25
Hemorrhage/Bleeding
24
24
Blood Loss
24
24
Toxicity
23
23
Hip Fracture
22
22
Insufficient Information
22
22
Anxiety
21
21
Local Reaction
19
19
Nerve Damage
17
17
Fever
17
17
Deformity/ Disfigurement
16
16
Depression
16
16
Muscular Rigidity
15
15
Post Operative Wound Infection
14
14
Dyspnea
13
13
Sepsis
11
11
Erosion
11
11
Wound Dehiscence
10
10
Aspiration/Inhalation
10
10
Bacterial Infection
10
10
Fibrosis
10
10
Joint Laxity
9
9
Foreign Body In Patient
9
9
Myocardial Infarction
9
9
Joint Swelling
9
9
Seroma
9
9
Scarring
8
8
Pocket Erosion
8
8
Stroke/CVA
8
8
Patient Problem/Medical Problem
8
8
Skin Irritation
8
8
Memory Loss/Impairment
8
8
Arthritis
7
7
Abscess
7
7
Osteopenia/ Osteoporosis
7
7
Cardiac Arrest
7
7
Headache
7
7
Sleep Dysfunction
6
6
Irritation
6
6
Neurological Deficit/Dysfunction
5
5
Rash
5
5
Renal Failure
5
5
Anemia
5
5
Hearing Impairment
5
5
Hypoesthesia
5
5
Nausea
5
5
Pneumonia
5
5
Tachycardia
5
5
Tinnitus
5
5
Unspecified Tissue Injury
5
5
Heart Failure
4
4
Itching Sensation
4
4
Fluid Discharge
4
4
Cognitive Changes
4
4
Calcium Deposits/Calcification
4
4
Neuropathy
4
4
Recalls
Manufacturer
Recall Class
Date Posted
1
Biomet, Inc.
II
Apr-03-2020
2
Smith & Nephew, Inc.
II
Nov-03-2016
3
Zimmer Biomet, Inc.
II
Nov-22-2019
4
Zimmer Biomet, Inc.
II
Nov-07-2018
5
Zimmer Biomet, Inc.
II
Mar-14-2018
6
Zimmer Biomet, Inc.
II
Feb-15-2018
7
Zimmer Biomet, Inc.
II
Feb-22-2016
8
Zimmer Manufacturing B.V.
II
Mar-12-2016
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