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TPLC
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Device
prosthesis, hip, hemi-, femoral, metal
Product Code
KWL
Regulation Number
888.3360
Device Class
2
Premarket Reviews
Manufacturer
Decision
HOWMEDICA OSTEONICS CORP., DBA STRYKER ORTHOPAEDICS
SUBSTANTIALLY EQUIVALENT
1
OSTEOREMEDIES LLC
SUBSTANTIALLY EQUIVALENT
1
OSTEOREMEDIES, LLC
SUBSTANTIALLY EQUIVALENT
3
MDR Year
MDR Reports
MDR Events
2018
295
295
2019
415
415
2020
269
269
2021
108
108
2022
99
99
2023
11
11
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
250
250
Device-Device Incompatibility
204
204
Material Twisted/Bent
113
113
Insufficient Information
112
112
Break
105
105
Appropriate Term/Code Not Available
86
86
Biocompatibility
81
81
Scratched Material
76
76
Loss of Osseointegration
50
50
Device Dislodged or Dislocated
44
44
Fitting Problem
44
44
Loose or Intermittent Connection
39
39
Corroded
31
31
Naturally Worn
29
29
Physical Resistance/Sticking
25
25
Osseointegration Problem
25
25
Fracture
24
24
Material Deformation
22
22
Migration
21
21
Degraded
18
18
Nonstandard Device
18
18
Device Contaminated During Manufacture or Shipping
16
16
Tear, Rip or Hole in Device Packaging
13
13
Inadequacy of Device Shape and/or Size
13
13
Migration or Expulsion of Device
13
13
Packaging Problem
12
12
Mechanical Jam
9
9
Material Integrity Problem
8
8
Difficult to Remove
8
8
Entrapment of Device
8
8
Patient Device Interaction Problem
8
8
Connection Problem
7
7
Defective Device
7
7
Patient-Device Incompatibility
6
6
Detachment of Device or Device Component
6
6
Failure to Osseointegrate
6
6
Difficult to Insert
6
6
Loss of or Failure to Bond
5
5
Malposition of Device
5
5
Loosening of Implant Not Related to Bone-Ingrowth
5
5
Compatibility Problem
4
4
Material Discolored
4
4
Crack
4
4
Material Fragmentation
3
3
Mechanical Problem
3
3
Unstable
3
3
Use of Device Problem
3
3
Unintended Movement
3
3
Difficult to Advance
2
2
Device Markings/Labelling Problem
2
2
Device Damaged Prior to Use
2
2
Defective Component
2
2
Unsealed Device Packaging
2
2
Failure To Adhere Or Bond
2
2
Detachment Of Device Component
2
2
Material Disintegration
1
1
Incorrect Measurement
1
1
Difficult To Position
1
1
Device Difficult to Setup or Prepare
1
1
Off-Label Use
1
1
Stretched
1
1
No Device Output
1
1
Overheating of Device
1
1
Device Issue
1
1
Vibration
1
1
Metal Shedding Debris
1
1
Dull, Blunt
1
1
Device Disinfection Or Sterilization Issue
1
1
No Apparent Adverse Event
1
1
Noise, Audible
1
1
Mechanics Altered
1
1
Therapeutic or Diagnostic Output Failure
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Positioning Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
382
382
No Code Available
273
273
Pain
236
236
Not Applicable
111
111
Unspecified Infection
105
105
Injury
104
104
Metal Related Pathology
93
93
Inadequate Osseointegration
87
87
Test Result
75
75
Bone Fracture(s)
65
65
Tissue Damage
46
46
Inflammation
45
45
Discomfort
45
45
Osteolysis
37
37
No Clinical Signs, Symptoms or Conditions
35
35
Joint Dislocation
33
33
Failure of Implant
32
32
Loss of Range of Motion
31
31
Foreign Body Reaction
31
31
Limited Mobility Of The Implanted Joint
28
28
Reaction
23
23
Insufficient Information
22
22
Fall
20
20
No Known Impact Or Consequence To Patient
17
17
Ambulation Difficulties
16
16
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
15
15
Blood Loss
14
14
No Information
13
13
Distress
12
12
Host-Tissue Reaction
11
11
Hypersensitivity/Allergic reaction
11
11
Swelling
11
11
Infiltration into Tissue
10
10
Edema
9
9
Necrosis
9
9
Hip Fracture
7
7
Weakness
7
7
Thrombosis
7
7
Anxiety
6
6
Swelling/ Edema
6
6
Hematoma
6
6
Toxicity
5
5
Synovitis
5
5
Fatigue
5
5
No Patient Involvement
4
4
Cyst(s)
4
4
Arthralgia
4
4
Depression
4
4
Myocardial Infarction
4
4
Joint Laxity
3
3
Bacterial Infection
3
3
Unspecified Tissue Injury
3
3
Ossification
3
3
Scar Tissue
3
3
Deformity/ Disfigurement
3
3
Muscle/Tendon Damage
2
2
Adhesion(s)
2
2
Pocket Erosion
2
2
Confusion/ Disorientation
2
2
Muscular Rigidity
2
2
Infarction, Cerebral
2
2
Non-union Bone Fracture
2
2
Joint Disorder
2
2
Renal Failure
2
2
Scarring
2
2
Solid Tumour
2
2
Nerve Damage
2
2
Thrombus
2
2
Calcium Deposits/Calcification
2
2
Rash
1
1
Abscess
1
1
Osteopenia/ Osteoporosis
1
1
Physical Asymmetry
1
1
Headache
1
1
Itching Sensation
1
1
Dizziness
1
1
Pneumonia
1
1
Unequal Limb Length
1
1
Hypoesthesia
1
1
Erosion
1
1
Diaphoresis
1
1
Respiratory Tract Infection
1
1
Local Reaction
1
1
Tinnitus
1
1
Hemorrhage/Bleeding
1
1
Patient Problem/Medical Problem
1
1
Arrhythmia
1
1
Stroke/CVA
1
1
Death
1
1
Foreign Body In Patient
1
1
Heart Failure
1
1
Implant Pain
1
1
Skin Infection
1
1
Pulmonary Embolism
1
1
Abrasion
1
1
Cardiomyopathy
1
1
Thrombosis/Thrombus
1
1
Renal Impairment
1
1
Limb Fracture
1
1
Hyperplasia
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
DePuy Orthopaedics, Inc.
II
Oct-11-2018
2
DePuy Orthopaedics, Inc.
II
Feb-12-2018
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