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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
MDR Year
MDR Reports
MDR Events
2019
335
335
2020
1046
1046
2021
1206
1206
2022
886
886
2023
289
289
2024
58
58
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
1695
1695
Fracture
496
496
Adverse Event Without Identified Device or Use Problem
277
277
Material Twisted/Bent
210
210
Crack
191
191
Material Deformation
156
156
Naturally Worn
115
115
Connection Problem
98
98
Defective Device
73
73
Material Fragmentation
65
65
Device Dislodged or Dislocated
63
63
Insufficient Information
61
61
Detachment of Device or Device Component
60
60
Loose or Intermittent Connection
51
51
Mechanical Problem
48
48
Incomplete or Inadequate Connection
41
41
Dull, Blunt
38
38
Mechanics Altered
37
37
Biocompatibility
34
34
Mechanical Jam
30
30
Corroded
27
27
Unstable
27
27
Flaked
26
26
Degraded
21
21
Loosening of Implant Not Related to Bone-Ingrowth
19
19
Physical Resistance/Sticking
18
18
Material Separation
18
18
Scratched Material
17
17
Peeled/Delaminated
16
16
Component Missing
15
15
Material Disintegration
14
14
Appropriate Term/Code Not Available
10
10
Material Erosion
9
9
Migration
9
9
Premature Separation
8
8
Inadequacy of Device Shape and/or Size
8
8
Loss of Osseointegration
8
8
Deformation Due to Compressive Stress
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
Solder Joint Fracture
5
5
Material Integrity Problem
5
5
Misconnection
4
4
Noise, Audible
4
4
Patient Device Interaction Problem
4
4
Malposition of Device
4
4
Loss of or Failure to Bond
4
4
Off-Label Use
4
4
Device Damaged Prior to Use
4
4
Material Split, Cut or Torn
4
4
Sharp Edges
4
4
Failure to Clean Adequately
3
3
Defective Component
3
3
Improper or Incorrect Procedure or Method
3
3
Fitting Problem
3
3
Use of Device Problem
3
3
Problem with Sterilization
3
3
Migration or Expulsion of Device
3
3
Separation Failure
3
3
Unintended Movement
3
3
No Apparent Adverse Event
3
3
Incomplete Coaptation
2
2
Device Damaged by Another Device
2
2
Difficult to Open or Close
2
2
Device Contaminated During Manufacture or Shipping
2
2
Device Appears to Trigger Rejection
2
2
Difficult to Remove
2
2
Delivered as Unsterile Product
2
2
Unclear Information
2
2
Device Fell
2
2
Activation Problem
1
1
Device Slipped
1
1
Failure to Reset
1
1
Unraveled Material
1
1
Failure to Osseointegrate
1
1
Misassembled
1
1
Difficult to Insert
1
1
Disconnection
1
1
Therapeutic or Diagnostic Output Failure
1
1
Device Handling Problem
1
1
Osseointegration Problem
1
1
Positioning Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
2486
2486
No Known Impact Or Consequence To Patient
353
353
No Patient Involvement
237
237
No Consequences Or Impact To Patient
207
207
No Code Available
104
104
Injury
103
103
Pain
91
91
Joint Dislocation
90
90
Failure of Implant
87
87
Unspecified Infection
74
74
Insufficient Information
59
59
No Information
46
46
Bone Fracture(s)
43
43
Test Result
41
41
Metal Related Pathology
35
35
Tissue Damage
34
34
Foreign Body In Patient
25
25
Osteolysis
23
23
Inadequate Osseointegration
22
22
Inflammation
18
18
Limited Mobility Of The Implanted Joint
17
17
Foreign Body Reaction
14
14
Loss of Range of Motion
14
14
Discomfort
12
12
Deformity/ Disfigurement
11
11
Thrombosis/Thrombus
10
10
Fall
9
9
Ambulation Difficulties
8
8
Reaction
7
7
Hip Fracture
7
7
Swelling
6
6
Subluxation
6
6
Device Embedded In Tissue or Plaque
5
5
Post Operative Wound Infection
5
5
Bacterial Infection
5
5
Fatigue
4
4
Death
4
4
Perforation
4
4
Nerve Damage
4
4
Non-union Bone Fracture
4
4
Swelling/ Edema
4
4
Not Applicable
3
3
Joint Laxity
3
3
Malunion of Bone
3
3
Muscle/Tendon Damage
3
3
Impaired Healing
3
3
Confusion/ Disorientation
3
3
Fluid Discharge
3
3
Local Reaction
3
3
Scar Tissue
3
3
Scarring
3
3
Necrosis
3
3
Arthritis
2
2
Cyst(s)
2
2
Host-Tissue Reaction
2
2
Ossification
2
2
Pulmonary Embolism
2
2
Osteopenia/ Osteoporosis
2
2
Joint Disorder
2
2
Synovitis
2
2
Dizziness
2
2
Balance Problems
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Unspecified Tissue Injury
2
2
Implant Pain
2
2
Movement Disorder
1
1
Fibrosis
1
1
Full thickness (Third Degree) Burn
1
1
Unequal Limb Length
1
1
Unspecified Musculoskeletal problem
1
1
Solid Tumour
1
1
Limb Fracture
1
1
Depression
1
1
Hypoesthesia
1
1
Arthralgia
1
1
Thrombosis
1
1
Vertigo
1
1
Weakness
1
1
Toxoplasmosis, Acquired
1
1
Ulcer
1
1
Anxiety
1
1
Needle Stick/Puncture
1
1
Skin Tears
1
1
Tissue Breakdown
1
1
Abscess
1
1
Adhesion(s)
1
1
Anemia
1
1
Arrhythmia
1
1
Cardiac Arrest
1
1
Infarction, Cerebral
1
1
Purulent Discharge
1
1
Edema
1
1
Emotional Changes
1
1
Hemorrhage/Bleeding
1
1
Hypersensitivity/Allergic reaction
1
1
Infiltration into Tissue
1
1
Memory Loss/Impairment
1
1
Muscular Rigidity
1
1
Nausea
1
1
Seroma
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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