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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
CORIN U.S.A.
SUBSTANTIALLY EQUIVALENT
1
HERAEUS MEDICAL GMBH
SUBSTANTIALLY EQUIVALENT
1
HOWMEDICA OSTEONICS CORP., DBA STRYKER ORTHOPAEDICS
SUBSTANTIALLY EQUIVALENT
1
MANDELL HORWITZ CONSULTANTS LLC
SUBSTANTIALLY EQUIVALENT
1
OSTEOREMEDIES LLC
SUBSTANTIALLY EQUIVALENT
1
1. K173967
Remedy Acetabular Cup
OSTEOREMEDIES, LLC
SUBSTANTIALLY EQUIVALENT
3
SIGNATURE ORTHOPAEDICS PTY LTD.
SUBSTANTIALLY EQUIVALENT
1
TECRES SPA
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
107
107
2015
222
222
2016
210
210
2017
347
347
2018
294
294
2019
415
415
2020
269
269
2021
107
107
2022
99
99
2023
49
49
2024
118
118
Device Problems
MDRs with this Device Problem
Events in those MDRs
Insufficient Information
520
520
Adverse Event Without Identified Device or Use Problem
360
360
Loss of Osseointegration
239
239
Device-Device Incompatibility
204
204
Appropriate Term/Code Not Available
187
187
Device Dislodged or Dislocated
143
143
Break
130
130
Material Twisted/Bent
113
113
Biocompatibility
103
103
Scratched Material
77
77
Corroded
66
66
Fracture
58
58
Migration or Expulsion of Device
57
57
Fitting Problem
57
57
Naturally Worn
50
50
Loose or Intermittent Connection
48
48
Degraded
36
36
Osseointegration Problem
30
30
Material Deformation
29
29
Nonstandard Device
26
26
Physical Resistance/Sticking
25
25
Inadequacy of Device Shape and/or Size
24
24
Migration
23
23
Detachment Of Device Component
17
17
Device Contaminated During Manufacture or Shipping
17
17
Malposition of Device
17
17
Loss of or Failure to Bond
16
16
Tear, Rip or Hole in Device Packaging
14
14
Device Operates Differently Than Expected
14
14
Packaging Problem
14
14
Material Integrity Problem
12
12
Difficult to Remove
11
11
Metal Shedding Debris
11
11
Mechanical Jam
10
10
Mechanical Problem
10
10
Noise, Audible
10
10
Device Slipped
9
9
Unstable
8
8
Entrapment of Device
8
8
Connection Problem
8
8
Detachment of Device or Device Component
8
8
Patient Device Interaction Problem
8
8
Positioning Problem
8
8
Computer System Security Problem
7
7
Patient-Device Incompatibility
7
7
Defective Device
7
7
Failure to Osseointegrate
7
7
Difficult to Insert
7
7
Crack
6
6
Compatibility Problem
6
6
Device Contamination with Chemical or Other Material
5
5
Material Erosion
5
5
Material Discolored
5
5
Loosening of Implant Not Related to Bone-Ingrowth
5
5
Use of Device Problem
4
4
Material Disintegration
3
3
Material Fragmentation
3
3
Failure To Adhere Or Bond
3
3
Manufacturing, Packaging or Shipping Problem
3
3
No Apparent Adverse Event
3
3
Unintended Movement
3
3
Therapeutic or Diagnostic Output Failure
2
2
Difficult to Advance
2
2
Device Markings/Labelling Problem
2
2
Device Damaged Prior to Use
2
2
Defective Component
2
2
Device Expiration Issue
2
2
Delivered as Unsterile Product
2
2
Unsealed Device Packaging
2
2
Difficult To Position
1
1
Device Difficult to Setup or Prepare
1
1
Off-Label Use
1
1
No Device Output
1
1
Overheating of Device
1
1
Vibration
1
1
Stretched
1
1
Device Inoperable
1
1
Incorrect Measurement
1
1
Disassembly
1
1
Microbial Contamination of Device
1
1
Residue After Decontamination
1
1
Device Issue
1
1
Improper or Incorrect Procedure or Method
1
1
Dull, Blunt
1
1
Device Disinfection Or Sterilization Issue
1
1
Device Packaging Compromised
1
1
Improper Chemical Reaction
1
1
Mechanics Altered
1
1
Misassembly by Users
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pain
517
517
No Code Available
405
405
No Consequences Or Impact To Patient
400
400
Injury
249
249
Unspecified Infection
236
236
Bone Fracture(s)
184
184
No Information
178
178
Not Applicable
116
116
Metal Related Pathology
113
113
Joint Dislocation
112
112
Insufficient Information
111
111
Inadequate Osseointegration
100
100
Discomfort
89
89
Test Result
79
79
Inflammation
75
75
Foreign Body Reaction
68
68
Osteolysis
64
64
Tissue Damage
62
62
Fall
57
57
No Known Impact Or Consequence To Patient
56
56
Failure of Implant
54
54
Host-Tissue Reaction
47
47
Ambulation Difficulties
44
44
Limited Mobility Of The Implanted Joint
43
43
Reaction
42
42
Loss of Range of Motion
40
40
No Clinical Signs, Symptoms or Conditions
35
35
Necrosis
21
21
Swelling
20
20
Distress
19
19
Hypersensitivity/Allergic reaction
17
17
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
16
16
Infiltration into Tissue
15
15
Edema
15
15
Weakness
15
15
Blood Loss
14
14
Toxicity
13
13
Synovitis
12
12
Leiomyosarcoma
11
11
Arthralgia
9
9
Hip Fracture
8
8
Thrombosis
8
8
Hematoma
8
8
Fatigue
7
7
Anxiety
7
7
Swelling/ Edema
7
7
Cyst(s)
6
6
Arthritis
6
6
Ossification
5
5
Adhesion(s)
5
5
Muscular Rigidity
5
5
Unspecified Tissue Injury
5
5
No Patient Involvement
5
5
Fluid Discharge
5
5
Depression
4
4
Joint Laxity
4
4
Implant Pain
4
4
Myocardial Infarction
4
4
Complaint, Ill-Defined
4
4
Malaise
3
3
Deformity/ Disfigurement
3
3
Scar Tissue
3
3
Muscle Weakness
3
3
Bacterial Infection
3
3
Death
3
3
Solid Tumour
3
3
Foreign Body In Patient
3
3
Osteopenia/ Osteoporosis
2
2
Non-union Bone Fracture
2
2
Joint Disorder
2
2
Confusion/ Disorientation
2
2
Numbness
2
2
Limb Fracture
2
2
Muscle/Tendon Damage
2
2
Erosion
2
2
Abscess
2
2
Itching Sensation
2
2
Infarction, Cerebral
2
2
Hemorrhage/Bleeding
2
2
Pocket Erosion
2
2
Nerve Damage
2
2
Scarring
2
2
Thrombus
2
2
Joint Swelling
2
2
Renal Failure
2
2
Heart Failure
1
1
Hypoesthesia
1
1
Tinnitus
1
1
Sepsis
1
1
Seroma
1
1
Pneumonia
1
1
Rash
1
1
Local Reaction
1
1
Hyperplasia
1
1
Headache
1
1
Fistula
1
1
Wound Dehiscence
1
1
Anemia
1
1
Pulmonary Embolism
1
1
Abrasion
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
DePuy Orthopaedics, Inc.
II
Oct-11-2018
2
DePuy Orthopaedics, Inc.
II
Feb-12-2018
3
Smith & Nephew, Inc.
II
Jan-05-2016
4
Stryker Howmedica Osteonics Corp.
III
Sep-14-2009
5
Stryker Howmedica Osteonics Corp.
II
Jul-22-2009
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