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TPLC
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Device
prosthesis, hip, femoral component, cemented, metal
Regulation Description
Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
Product Code
JDG
Regulation Number
888.3360
Device Class
2
Premarket Reviews
Manufacturer
Decision
BIOMET INC.
SUBSTANTIALLY EQUIVALENT
1
BIOMET, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
1046
1046
2021
1206
1206
2022
886
886
2023
289
289
2024
301
301
2025
57
57
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
1671
1671
Fracture
681
681
Material Twisted/Bent
214
214
Adverse Event Without Identified Device or Use Problem
209
209
Crack
192
192
Material Deformation
160
160
Naturally Worn
106
106
Connection Problem
85
85
Detachment of Device or Device Component
73
73
Defective Device
73
73
Material Fragmentation
72
72
Device Dislodged or Dislocated
53
53
Loose or Intermittent Connection
49
49
Mechanical Problem
48
48
Incomplete or Inadequate Connection
41
41
Dull, Blunt
38
38
Mechanics Altered
38
38
Mechanical Jam
32
32
Flaked
25
25
Biocompatibility
24
24
Loosening of Implant Not Related to Bone-Ingrowth
19
19
Material Separation
18
18
Physical Resistance/Sticking
18
18
Peeled/Delaminated
17
17
Corroded
17
17
Scratched Material
17
17
Component Missing
15
15
Material Disintegration
14
14
Degraded
13
13
Insufficient Information
10
10
Premature Separation
9
9
Deformation Due to Compressive Stress
8
8
Activation, Positioning or Separation Problem
8
8
Solder Joint Fracture
8
8
Inadequacy of Device Shape and/or Size
8
8
Unstable
7
7
Material Erosion
7
7
Nonstandard Device
7
7
Appropriate Term/Code Not Available
6
6
Migration
6
6
Difficult or Delayed Separation
6
6
Failure to Align
5
5
Separation Failure
5
5
Positioning Failure
5
5
Migration or Expulsion of Device
4
4
Misconnection
4
4
Device Damaged Prior to Use
4
4
Off-Label Use
4
4
Malposition of Device
4
4
Material Integrity Problem
4
4
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
2743
2743
No Known Impact Or Consequence To Patient
350
350
No Patient Involvement
237
237
No Consequences Or Impact To Patient
119
119
Failure of Implant
91
91
Joint Dislocation
81
81
Insufficient Information
65
65
Pain
47
47
Metal Related Pathology
37
37
Unspecified Infection
36
36
Bone Fracture(s)
30
30
No Information
27
27
Foreign Body In Patient
25
25
Injury
23
23
Inadequate Osseointegration
19
19
Osteolysis
11
11
Deformity/ Disfigurement
10
10
Thrombosis/Thrombus
10
10
Fall
9
9
No Code Available
8
8
Foreign Body Reaction
7
7
Subluxation
6
6
Ambulation Difficulties
6
6
Loss of Range of Motion
5
5
Device Embedded In Tissue or Plaque
5
5
Post Operative Wound Infection
5
5
Hip Fracture
5
5
Bacterial Infection
5
5
Inflammation
5
5
Perforation
4
4
Non-union Bone Fracture
4
4
Swelling/ Edema
4
4
Hemorrhage/Bleeding
4
4
Muscle/Tendon Damage
4
4
Confusion/ Disorientation
3
3
Joint Laxity
3
3
Nerve Damage
3
3
Impaired Healing
3
3
Fluid Discharge
3
3
Malunion of Bone
3
3
Osteopenia/ Osteoporosis
2
2
Implant Pain
2
2
Ossification
2
2
Synovitis
2
2
Unspecified Tissue Injury
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Dizziness
2
2
Balance Problems
2
2
Laceration(s)
2
2
Tissue Breakdown
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Howmedica Osteonics Corp.
II
Feb-17-2022
2
Howmedica Osteonics Corp.
II
Nov-30-2021
3
Waldemar Link GmbH & Co. KG (Mfg Site)
II
Mar-14-2024
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