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TPLC
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Device
prosthesis, hip, hemi-, trunnion-bearing, femoral, metal/polyacetal
Product Code
JDH
Regulation Number
888.3380
Device Class
3
MDR Year
MDR Reports
MDR Events
2016
94
94
2017
82
82
2018
223
223
2019
354
354
2020
292
292
2021
158
158
2022
76
76
2023
5
5
Device Problems
MDRs with this Device Problem
Events in those MDRs
Insufficient Information
385
385
Adverse Event Without Identified Device or Use Problem
290
290
Device Dislodged or Dislocated
132
132
Break
85
85
Fracture
78
78
Loosening of Implant Not Related to Bone-Ingrowth
49
49
Naturally Worn
46
46
Loose or Intermittent Connection
42
42
Appropriate Term/Code Not Available
31
31
Unintended Movement
22
22
Biocompatibility
20
20
Corroded
15
15
Unstable
15
15
Migration or Expulsion of Device
10
10
Degraded
10
10
Material Deformation
9
9
Detachment Of Device Component
8
8
Patient Device Interaction Problem
8
8
Loss of Osseointegration
7
7
Material Integrity Problem
7
7
Compatibility Problem
7
7
Metal Shedding Debris
6
6
Noise, Audible
6
6
Device Operates Differently Than Expected
5
5
Migration
4
4
Connection Problem
4
4
Device Slipped
4
4
Material Erosion
4
4
Malposition of Device
4
4
Material Separation
4
4
Mechanical Jam
3
3
Device Damaged by Another Device
3
3
Incomplete or Inadequate Connection
3
3
Fitting Problem
3
3
Positioning Problem
3
3
Mechanical Problem
3
3
Crack
3
3
Misassembled
3
3
Activation, Positioning or Separation Problem
3
3
Failure To Adhere Or Bond
3
3
Patient-Device Incompatibility
3
3
Pitted
3
3
Osseointegration Problem
2
2
Contamination /Decontamination Problem
2
2
Inadequacy of Device Shape and/or Size
2
2
Separation Failure
2
2
Off-Label Use
2
2
Material Fragmentation
1
1
Device Handling Problem
1
1
Unclear Information
1
1
Positioning Failure
1
1
Device Contamination with Chemical or Other Material
1
1
Physical Resistance/Sticking
1
1
Accessory Incompatible
1
1
Device-Device Incompatibility
1
1
Nonstandard Device
1
1
Detachment of Device or Device Component
1
1
Device Expiration Issue
1
1
Failure to Convert to Back-Up
1
1
Disconnection
1
1
Material Rupture
1
1
Difficult to Insert
1
1
Dull, Blunt
1
1
Loss of or Failure to Bond
1
1
Use of Device Problem
1
1
Component Missing
1
1
Material Twisted/Bent
1
1
Failure to Osseointegrate
1
1
Illegible Information
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Injury
526
526
Unspecified Infection
145
145
Joint Dislocation
108
108
Pain
104
104
No Clinical Signs, Symptoms or Conditions
95
95
Failure of Implant
82
82
Bone Fracture(s)
79
79
No Code Available
60
60
No Information
50
50
Metal Related Pathology
41
41
No Known Impact Or Consequence To Patient
40
40
No Consequences Or Impact To Patient
32
32
Hip Fracture
19
19
Osteolysis
17
17
Inadequate Osseointegration
12
12
Thrombosis/Thrombus
10
10
Insufficient Information
10
10
Loss of Range of Motion
10
10
Necrosis
8
8
Test Result
8
8
Ambulation Difficulties
8
8
Inflammation
6
6
Discomfort
5
5
Implant Pain
5
5
Swelling/ Edema
4
4
Subluxation
4
4
Joint Laxity
4
4
Fall
4
4
Hematoma
3
3
Ossification
3
3
Toxicity
3
3
Thrombosis
3
3
Neuralgia
3
3
Unequal Limb Length
3
3
Foreign Body In Patient
3
3
Non-union Bone Fracture
3
3
Joint Disorder
3
3
Post Operative Wound Infection
3
3
Tissue Breakdown
2
2
Scar Tissue
2
2
Arthralgia
2
2
Bacterial Infection
2
2
Cyst(s)
2
2
Death
2
2
Hemorrhage/Bleeding
2
2
Muscular Rigidity
2
2
Laceration(s)
1
1
Muscle Weakness
1
1
Fistula
1
1
Foreign Body Sensation in Eye
1
1
Infiltration into Tissue
1
1
Hypersensitivity/Allergic reaction
1
1
Debris, Bone Shedding
1
1
Chest Pain
1
1
Deformity/ Disfigurement
1
1
Complaint, Ill-Defined
1
1
Sepsis
1
1
Swelling
1
1
Synovitis
1
1
Tachycardia
1
1
Tissue Damage
1
1
Ventricular Fibrillation
1
1
Hernia
1
1
Wheal(s)
1
1
No Patient Involvement
1
1
Osteopenia/ Osteoporosis
1
1
Thromboembolism
1
1
Limited Mobility Of The Implanted Joint
1
1
Disability
1
1
Impaired Healing
1
1
Reaction
1
1
Unspecified Musculoskeletal problem
1
1
Skin Infection
1
1
Muscle/Tendon Damage
1
1
Cardiovascular Insufficiency
1
1
Unspecified Heart Problem
1
1
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