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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
DEPUY IRELAND UC
SUBSTANTIALLY EQUIVALENT
1
1. K231526
CORAIL Cemented Femoral Stem
G21, S.R.L.
SUBSTANTIALLY EQUIVALENT
1
HERAEUS MEDICAL GMBH
SUBSTANTIALLY EQUIVALENT
1
KYOCERA MEDICAL TECHNOLOGIES, INC.
SUBSTANTIALLY EQUIVALENT
1
WALDEMAR LINK GMBH & CO. KG
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
1260
1260
2021
276
276
2022
208
208
2023
178
178
2024
210
210
2025
13
13
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
1010
1010
Device Dislodged or Dislocated
444
444
Naturally Worn
134
134
Fracture
111
111
Difficult to Insert
72
72
Insufficient Information
62
62
Migration
56
56
Loss of Osseointegration
49
49
Appropriate Term/Code Not Available
39
39
Loosening of Implant Not Related to Bone-Ingrowth
30
30
Noise, Audible
30
30
Material Erosion
29
29
Detachment of Device or Device Component
27
27
Loss of or Failure to Bond
24
24
Device Contaminated During Manufacture or Shipping
21
21
Degraded
20
20
Corroded
20
20
Osseointegration Problem
19
19
Break
18
18
Unintended Movement
16
16
Malposition of Device
15
15
Patient Device Interaction Problem
15
15
Nonstandard Device
14
14
Use of Device Problem
14
14
Positioning Failure
13
13
Unstable
11
11
Device-Device Incompatibility
9
9
Mechanical Problem
7
7
Separation Failure
7
7
Biocompatibility
6
6
Off-Label Use
6
6
No Apparent Adverse Event
5
5
Fitting Problem
5
5
Mechanical Jam
5
5
Material Integrity Problem
5
5
Positioning Problem
4
4
Failure to Osseointegrate
4
4
Crack
4
4
Loose or Intermittent Connection
4
4
Packaging Problem
4
4
Tear, Rip or Hole in Device Packaging
3
3
Device Damaged Prior to Use
3
3
Difficult to Remove
3
3
Activation, Positioning or Separation Problem
3
3
Expiration Date Error
3
3
Manufacturing, Packaging or Shipping Problem
3
3
Patient-Device Incompatibility
2
2
Deformation Due to Compressive Stress
2
2
Scratched Material
2
2
Separation Problem
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Code Available
854
854
Pain
494
494
Joint Dislocation
395
395
Unspecified Infection
332
332
Test Result
171
171
Foreign Body Reaction
156
156
No Clinical Signs, Symptoms or Conditions
138
138
Bone Fracture(s)
119
119
Insufficient Information
117
117
Failure of Implant
110
110
Inadequate Osseointegration
73
73
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
73
73
Osteolysis
70
70
Hypersensitivity/Allergic reaction
63
63
Joint Laxity
62
62
Fall
60
60
Discomfort
52
52
Injury
44
44
Edema
42
42
No Consequences Or Impact To Patient
41
41
Limited Mobility Of The Implanted Joint
40
40
Hematoma
39
39
Metal Related Pathology
38
38
No Information
38
38
Ambulation Difficulties
36
36
Necrosis
31
31
No Known Impact Or Consequence To Patient
29
29
Inflammation
27
27
Tissue Damage
23
23
Not Applicable
23
23
Loss of Range of Motion
23
23
Adhesion(s)
21
21
Thrombosis
19
19
Ossification
18
18
Cyst(s)
18
18
No Patient Involvement
18
18
Fatigue
17
17
Hip Fracture
16
16
Nerve Damage
14
14
Hemorrhage/Bleeding
14
14
Weakness
14
14
Pulmonary Embolism
12
12
Osteopenia/ Osteoporosis
12
12
Impaired Healing
12
12
Unspecified Tissue Injury
11
11
Local Reaction
11
11
Swelling/ Edema
10
10
Muscle/Tendon Damage
10
10
Arthralgia
10
10
Scar Tissue
10
10
Recalls
Manufacturer
Recall Class
Date Posted
1
Biomet, Inc.
II
Apr-03-2020
2
Exactech, Inc.
II
Jun-28-2024
3
Smith & Nephew, Inc.
II
Nov-07-2024
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