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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
294
294
2019
415
415
2020
269
269
2021
107
107
2022
98
98
2023
40
40
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
259
259
Device-Device Incompatibility
204
204
Insufficient Information
118
118
Material Twisted/Bent
113
113
Break
105
105
Biocompatibility
95
95
Appropriate Term/Code Not Available
84
84
Scratched Material
76
76
Loss of Osseointegration
50
50
Device Dislodged or Dislocated
47
47
Fitting Problem
44
44
Loose or Intermittent Connection
39
39
Corroded
30
30
Naturally Worn
30
30
Physical Resistance/Sticking
25
25
Osseointegration Problem
25
25
Fracture
24
24
Material Deformation
22
22
Migration
21
21
Degraded
19
19
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
272
272
Pain
237
237
Not Applicable
111
111
Unspecified Infection
110
110
Injury
103
103
Metal Related Pathology
103
103
Inadequate Osseointegration
87
87
Test Result
74
74
Bone Fracture(s)
65
65
Tissue Damage
46
46
Inflammation
45
45
Discomfort
44
44
Osteolysis
40
40
Joint Dislocation
36
36
No Clinical Signs, Symptoms or Conditions
35
35
Failure of Implant
32
32
Foreign Body Reaction
30
30
Loss of Range of Motion
29
29
Insufficient Information
28
28
Limited Mobility Of The Implanted Joint
28
28
Reaction
23
23
Fall
20
20
Ambulation Difficulties
18
18
No Known Impact Or Consequence To Patient
17
17
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
15
15
Infiltration into Tissue
15
15
Blood Loss
14
14
No Information
13
13
Host-Tissue Reaction
11
11
Distress
11
11
Swelling
11
11
Hypersensitivity/Allergic reaction
10
10
Necrosis
10
10
Edema
9
9
Hematoma
7
7
Thrombosis
7
7
Hip Fracture
7
7
Arthralgia
7
7
Anxiety
6
6
Weakness
6
6
Swelling/ Edema
6
6
Synovitis
5
5
Toxicity
5
5
Cyst(s)
5
5
Fatigue
4
4
Myocardial Infarction
4
4
Depression
4
4
Implant Pain
4
4
No Patient Involvement
4
4
Joint Laxity
3
3
Solid Tumour
3
3
Unspecified Tissue Injury
3
3
Deformity/ Disfigurement
3
3
Scar Tissue
3
3
Ossification
3
3
Bacterial Infection
3
3
Infarction, Cerebral
2
2
Adhesion(s)
2
2
Nerve Damage
2
2
Muscle Weakness
2
2
Muscular Rigidity
2
2
Scarring
2
2
Pocket Erosion
2
2
Renal Failure
2
2
Thrombus
2
2
Non-union Bone Fracture
2
2
Joint Disorder
2
2
Confusion/ Disorientation
2
2
Muscle/Tendon Damage
2
2
Unequal Limb Length
1
1
Skin Infection
1
1
Physical Asymmetry
1
1
Thrombosis/Thrombus
1
1
Renal Impairment
1
1
Limb Fracture
1
1
Osteopenia/ Osteoporosis
1
1
Foreign Body In Patient
1
1
Patient Problem/Medical Problem
1
1
Numbness
1
1
Respiratory Tract Infection
1
1
Hypoesthesia
1
1
Tinnitus
1
1
Heart Failure
1
1
Sepsis
1
1
Rash
1
1
Local Reaction
1
1
Pneumonia
1
1
Itching Sensation
1
1
Hemorrhage/Bleeding
1
1
Hyperplasia
1
1
Headache
1
1
Wound Dehiscence
1
1
Death
1
1
Calcium Deposits/Calcification
1
1
Cardiomyopathy
1
1
Stroke/CVA
1
1
Pulmonary Embolism
1
1
Abrasion
1
1
Abscess
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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