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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
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
ONKOS SURGICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
SIGNATURE ORTHOPAEDICS PTY LTD.
SUBSTANTIALLY EQUIVALENT
1
SURGTECH, INC.,
SUBSTANTIALLY EQUIVALENT
1
THEKEN COMPANIES, LLC
SUBSTANTIALLY EQUIVALENT
1
WALDEMAR LINK GMBH & CO. KG
SUBSTANTIALLY EQUIVALENT
1
ZIMMER GMBH
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
1387
1387
2019
1534
1534
2020
1272
1272
2021
278
278
2022
210
210
2023
71
71
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
1723
1723
Device Dislodged or Dislocated
987
987
Insufficient Information
650
650
Naturally Worn
486
486
Fracture
193
193
Appropriate Term/Code Not Available
168
168
Loss of Osseointegration
96
96
Migration
88
88
Corroded
86
86
Difficult to Insert
85
85
Noise, Audible
78
78
Material Erosion
67
67
Loss of or Failure to Bond
43
43
Break
41
41
Detachment of Device or Device Component
40
40
Biocompatibility
40
40
Loosening of Implant Not Related to Bone-Ingrowth
40
40
Nonstandard Device
34
34
Degraded
33
33
Osseointegration Problem
33
33
Malposition of Device
31
31
Migration or Expulsion of Device
29
29
Unintended Movement
26
26
Loose or Intermittent Connection
25
25
Use of Device Problem
24
24
Device Contaminated During Manufacture or Shipping
21
21
Unstable
20
20
Delivered as Unsterile Product
20
20
Patient Device Interaction Problem
17
17
Fitting Problem
16
16
Packaging Problem
14
14
Metal Shedding Debris
12
12
Difficult to Remove
11
11
Positioning Failure
11
11
Separation Failure
10
10
Device-Device Incompatibility
10
10
Failure to Osseointegrate
9
9
Material Disintegration
9
9
Patient-Device Incompatibility
8
8
No Apparent Adverse Event
8
8
Positioning Problem
7
7
Inadequacy of Device Shape and/or Size
7
7
Disassembly
7
7
Off-Label Use
7
7
Mechanical Problem
6
6
Tear, Rip or Hole in Device Packaging
5
5
Contamination /Decontamination Problem
5
5
Scratched Material
5
5
Mechanical Jam
4
4
Material Deformation
4
4
Difficult To Position
4
4
Device Appears to Trigger Rejection
3
3
Defective Device
3
3
Activation, Positioning or Separation Problem
3
3
Device Markings/Labelling Problem
3
3
Expiration Date Error
3
3
Material Separation
3
3
Material Integrity Problem
3
3
Manufacturing, Packaging or Shipping Problem
3
3
Physical Resistance/Sticking
3
3
Separation Problem
2
2
Material Twisted/Bent
2
2
Improper or Incorrect Procedure or Method
2
2
Dull, Blunt
2
2
Device Damaged Prior to Use
2
2
Device Contamination with Chemical or Other Material
2
2
Human-Device Interface Problem
2
2
Connection Problem
2
2
Deformation Due to Compressive Stress
2
2
Material Too Rigid or Stiff
2
2
Contamination
2
2
Device Expiration Issue
2
2
Difficult or Delayed Positioning
2
2
Crack
2
2
Detachment Of Device Component
1
1
Failure To Adhere Or Bond
1
1
Bent
1
1
Material Discolored
1
1
Disconnection
1
1
Device Difficult to Setup or Prepare
1
1
Misassembled
1
1
Peeled/Delaminated
1
1
Pitted
1
1
Incorrect Measurement
1
1
Compatibility Problem
1
1
Installation-Related Problem
1
1
Device Packaging Compromised
1
1
Component Missing
1
1
Incomplete or Missing Packaging
1
1
Failure to Disconnect
1
1
Shipping Damage or Problem
1
1
No Fail-Safe Mechanism
1
1
Inaccurate Information
1
1
Unclear Information
1
1
Activation Problem
1
1
Component Misassembled
1
1
Material Split, Cut or Torn
1
1
Misassembly by Users
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Code Available
2257
2260
Pain
1542
1543
Joint Dislocation
913
914
Unspecified Infection
711
712
Test Result
521
521
Foreign Body Reaction
401
401
Injury
387
387
Not Applicable
288
288
Tissue Damage
280
280
Osteolysis
278
278
Discomfort
197
197
No Information
192
192
Bone Fracture(s)
192
192
Limited Mobility Of The Implanted Joint
183
183
Inflammation
182
182
Hypersensitivity/Allergic reaction
172
172
No Consequences Or Impact To Patient
147
147
Inadequate Osseointegration
140
140
Reaction
128
128
Loss of Range of Motion
122
122
No Clinical Signs, Symptoms or Conditions
101
101
Failure of Implant
88
88
Hematoma
88
88
Ambulation Difficulties
81
81
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
81
81
Insufficient Information
79
79
Necrosis
79
79
Edema
77
77
No Known Impact Or Consequence To Patient
72
72
Thrombosis
65
65
Fall
65
65
Distress
59
59
Weakness
55
55
Pulmonary Embolism
50
50
Swelling
49
49
No Patient Involvement
47
47
Host-Tissue Reaction
45
45
Adhesion(s)
44
44
Fatigue
39
39
Metal Related Pathology
39
39
Joint Laxity
36
36
Ossification
34
34
Impaired Healing
34
34
Scar Tissue
33
33
Cyst(s)
29
29
Hemorrhage/Bleeding
27
27
Joint Disorder
23
23
Hip Fracture
23
23
Anxiety
22
22
Blood Loss
22
22
Local Reaction
21
21
Nerve Damage
20
20
Death
20
20
Unspecified Tissue Injury
19
19
Swelling/ Edema
17
17
Bacterial Infection
17
17
Deformity/ Disfigurement
17
17
Fever
16
16
Depression
15
15
Synovitis
14
14
Osteopenia/ Osteoporosis
14
14
Toxicity
12
12
Wound Dehiscence
12
12
Muscular Rigidity
11
11
Post Operative Wound Infection
11
11
Sepsis
10
10
Erosion
10
10
Dyspnea
10
10
Myocardial Infarction
9
9
Pocket Erosion
9
9
Physical Asymmetry
9
9
Fibrosis
9
9
Muscle/Tendon Damage
8
8
Stroke/CVA
8
8
Seroma
8
8
Patient Problem/Medical Problem
8
8
Foreign Body In Patient
7
7
Skin Irritation
7
7
Tinnitus
6
6
Fluid Discharge
6
6
Sleep Dysfunction
6
6
Calcium Deposits/Calcification
6
6
Cardiac Arrest
6
6
Memory Loss/Impairment
6
6
Hearing Impairment
6
6
Headache
5
5
Nausea
5
5
Rash
5
5
Renal Failure
5
5
Scarring
5
5
Neurological Deficit/Dysfunction
5
5
Abscess
5
5
Anemia
5
5
Tachycardia
5
5
Arthralgia
5
5
Implant Pain
5
5
Hypoesthesia
4
4
Heart Failure
4
4
Vertigo
4
4
Cognitive Changes
4
4
Recalls
Manufacturer
Recall Class
Date Posted
1
Biomet, Inc.
II
Apr-03-2020
2
Zimmer Biomet, Inc.
II
Nov-22-2019
3
Zimmer Biomet, Inc.
II
Nov-07-2018
4
Zimmer Biomet, Inc.
II
Mar-14-2018
5
Zimmer Biomet, Inc.
II
Feb-15-2018
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