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TPLC
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Device
prosthesis, hip, femoral component, cemented, metal
Product Code
JDG
Regulation Number
888.3360
Device Class
2
Premarket Reviews
Manufacturer
Decision
BIOMET INC.
SUBSTANTIALLY EQUIVALENT
1
BIOMET, INC.
SUBSTANTIALLY EQUIVALENT
1
STRYKER ORTHOPAEDICS
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
452
452
2019
336
336
2020
1046
1046
2021
1209
1209
2022
897
897
2023
95
95
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
1677
1677
Fracture
342
342
Adverse Event Without Identified Device or Use Problem
341
341
Insufficient Information
267
267
Material Twisted/Bent
209
209
Crack
191
191
Material Deformation
159
159
Naturally Worn
127
127
Connection Problem
98
98
Device Dislodged or Dislocated
93
93
Defective Device
73
73
Material Fragmentation
64
64
Loose or Intermittent Connection
53
53
Detachment of Device or Device Component
51
51
Mechanical Problem
49
49
Corroded
41
41
Incomplete or Inadequate Connection
41
41
Dull, Blunt
38
38
Biocompatibility
37
37
Mechanics Altered
37
37
Appropriate Term/Code Not Available
36
36
Unstable
31
31
Mechanical Jam
30
30
Degraded
27
27
Flaked
26
26
Material Erosion
19
19
Loosening of Implant Not Related to Bone-Ingrowth
19
19
Migration
18
18
Material Separation
18
18
Scratched Material
17
17
Loss of Osseointegration
17
17
Component Missing
16
16
Peeled/Delaminated
16
16
Material Disintegration
15
15
Physical Resistance/Sticking
15
15
Noise, Audible
11
11
Loss of or Failure to Bond
10
10
Migration or Expulsion of Device
9
9
Inadequacy of Device Shape and/or Size
8
8
Malposition of Device
8
8
Activation, Positioning or Separation Problem
8
8
Nonstandard Device
7
7
Failure to Align
7
7
Premature Separation
7
7
Difficult or Delayed Separation
6
6
Solder Joint Fracture
6
6
Deformation Due to Compressive Stress
6
6
Positioning Problem
5
5
Material Integrity Problem
5
5
Positioning Failure
5
5
Difficult to Insert
4
4
Misconnection
4
4
Fitting Problem
4
4
Device Damaged Prior to Use
4
4
Osseointegration Problem
4
4
No Apparent Adverse Event
4
4
Patient Device Interaction Problem
4
4
Sharp Edges
4
4
Material Split, Cut or Torn
4
4
Failure to Clean Adequately
3
3
Unintended Movement
3
3
Separation Failure
3
3
Defective Component
3
3
Problem with Sterilization
3
3
Use of Device Problem
3
3
Off-Label Use
3
3
Difficult to Remove
3
3
Device Appears to Trigger Rejection
2
2
Metal Shedding Debris
2
2
Failure to Osseointegrate
2
2
Failure To Adhere Or Bond
2
2
Incomplete Coaptation
2
2
Difficult to Open or Close
2
2
Device Damaged by Another Device
2
2
Device Contaminated During Manufacture or Shipping
2
2
Device Fell
2
2
Device Handling Problem
2
2
Activation Problem
1
1
Device Contamination with Chemical or Other Material
1
1
Therapeutic or Diagnostic Output Failure
1
1
Device-Device Incompatibility
1
1
Tear, Rip or Hole in Device Packaging
1
1
Disconnection
1
1
Misassembled
1
1
Improper or Incorrect Procedure or Method
1
1
Unraveled Material
1
1
Failure to Reset
1
1
Device Slipped
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
2288
2288
No Known Impact Or Consequence To Patient
370
370
No Patient Involvement
238
238
Pain
219
219
No Consequences Or Impact To Patient
215
215
Injury
186
186
No Code Available
163
163
Joint Dislocation
117
117
Unspecified Infection
108
108
No Information
107
107
Failure of Implant
85
85
Inflammation
65
65
Test Result
64
64
Not Applicable
61
61
Tissue Damage
59
59
Insufficient Information
57
57
Bone Fracture(s)
55
55
Reaction
52
52
Inadequate Osseointegration
38
38
Discomfort
38
38
Osteolysis
38
38
Metal Related Pathology
34
34
Limited Mobility Of The Implanted Joint
28
28
Foreign Body In Patient
24
24
Loss of Range of Motion
21
21
Foreign Body Reaction
20
20
Deformity/ Disfigurement
15
15
Ambulation Difficulties
14
14
Fall
11
11
Swelling
11
11
Thrombosis/Thrombus
9
9
Bacterial Infection
9
9
Blood Loss
9
9
Local Reaction
8
8
Hip Fracture
8
8
Impaired Healing
8
8
Necrosis
7
7
Hypersensitivity/Allergic reaction
6
6
Distress
6
6
Post Operative Wound Infection
6
6
Death
6
6
Subluxation
6
6
Thrombosis
5
5
Fatigue
5
5
Wound Dehiscence
5
5
Host-Tissue Reaction
5
5
Perforation
4
4
Device Embedded In Tissue or Plaque
4
4
Depression
4
4
Hematoma
4
4
Non-union Bone Fracture
4
4
Scar Tissue
4
4
Confusion/ Disorientation
4
4
Malunion of Bone
3
3
Cyst(s)
3
3
Weakness
3
3
Infiltration into Tissue
3
3
Muscle/Tendon Damage
3
3
Swelling/ Edema
3
3
Fluid Discharge
3
3
Nerve Damage
3
3
Scarring
3
3
Unequal Limb Length
3
3
Synovitis
2
2
Dizziness
2
2
Peroneal Nerve Palsy
2
2
Balance Problems
2
2
Rupture
2
2
Toxicity
2
2
Osteopenia/ Osteoporosis
2
2
Joint Laxity
2
2
Joint Disorder
2
2
Urinary Tract Infection
2
2
Ossification
2
2
Arthritis
2
2
Nausea
2
2
Cellulitis
2
2
Implant Pain
2
2
Arrhythmia
1
1
Muscular Rigidity
1
1
Arthralgia
1
1
Unspecified Tissue Injury
1
1
Movement Disorder
1
1
Pulmonary Embolism
1
1
Muscle Spasm(s)
1
1
Vertigo
1
1
Adhesion(s)
1
1
Respiratory Distress
1
1
Anxiety
1
1
Ventilator Dependent
1
1
Tissue Breakdown
1
1
Full thickness (Third Degree) Burn
1
1
Fibrosis
1
1
Limb Fracture
1
1
Unspecified Musculoskeletal problem
1
1
Anemia
1
1
Emotional Changes
1
1
Ulcer
1
1
Toxoplasmosis, Acquired
1
1
Joint Swelling
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Howmedica Osteonics Corp.
II
Feb-17-2022
2
Howmedica Osteonics Corp.
II
Nov-30-2021
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