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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
2019
334
334
2020
1046
1046
2021
1206
1206
2022
886
886
2023
289
289
2024
301
301
2025
11
11
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
1726
1726
Fracture
677
677
Adverse Event Without Identified Device or Use Problem
287
287
Material Twisted/Bent
212
212
Crack
192
192
Material Deformation
159
159
Naturally Worn
115
115
Connection Problem
98
98
Device Dislodged or Dislocated
81
81
Defective Device
73
73
Material Fragmentation
70
70
Detachment of Device or Device Component
70
70
Insufficient Information
61
61
Loose or Intermittent Connection
51
51
Mechanical Problem
48
48
Incomplete or Inadequate Connection
41
41
Dull, Blunt
38
38
Mechanics Altered
38
38
Biocompatibility
36
36
Mechanical Jam
33
33
Corroded
28
28
Unstable
27
27
Flaked
26
26
Loosening of Implant Not Related to Bone-Ingrowth
23
23
Degraded
22
22
Physical Resistance/Sticking
18
18
Material Separation
18
18
Scratched Material
17
17
Peeled/Delaminated
17
17
Component Missing
15
15
Material Disintegration
14
14
Material Erosion
10
10
Appropriate Term/Code Not Available
10
10
Migration
9
9
Inadequacy of Device Shape and/or Size
9
9
Premature Separation
8
8
Loss of Osseointegration
8
8
Deformation Due to Compressive Stress
8
8
Solder Joint Fracture
8
8
Activation, Positioning or Separation Problem
8
8
Failure to Align
7
7
Nonstandard Device
7
7
Difficult or Delayed Separation
6
6
Positioning Failure
5
5
Material Integrity Problem
5
5
Device Damaged Prior to Use
4
4
Patient Device Interaction Problem
4
4
Noise, Audible
4
4
Unintended Movement
4
4
Sharp Edges
4
4
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
2702
2702
No Known Impact Or Consequence To Patient
353
353
No Patient Involvement
237
237
No Consequences Or Impact To Patient
207
207
Joint Dislocation
108
108
No Code Available
104
104
Injury
102
102
Failure of Implant
98
98
Pain
96
96
Unspecified Infection
74
74
Insufficient Information
63
63
No Information
46
46
Bone Fracture(s)
45
45
Test Result
41
41
Metal Related Pathology
38
38
Tissue Damage
34
34
Inadequate Osseointegration
27
27
Foreign Body In Patient
25
25
Osteolysis
24
24
Inflammation
18
18
Limited Mobility Of The Implanted Joint
17
17
Loss of Range of Motion
14
14
Foreign Body Reaction
14
14
Fall
12
12
Discomfort
12
12
Deformity/ Disfigurement
11
11
Thrombosis/Thrombus
10
10
Ambulation Difficulties
8
8
Reaction
7
7
Hip Fracture
7
7
Swelling
6
6
Device Embedded In Tissue or Plaque
6
6
Subluxation
6
6
Bacterial Infection
5
5
Post Operative Wound Infection
5
5
Perforation
4
4
Nerve Damage
4
4
Non-union Bone Fracture
4
4
Swelling/ Edema
4
4
Death
4
4
Fatigue
4
4
Hemorrhage/Bleeding
4
4
Muscle/Tendon Damage
4
4
Scarring
3
3
Scar Tissue
3
3
Local Reaction
3
3
Necrosis
3
3
Not Applicable
3
3
Fluid Discharge
3
3
Osteopenia/ Osteoporosis
3
3
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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