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TPLC
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Device
prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate
Product Code
MEH
Regulation Number
888.3353
Device Class
2
Premarket Reviews
Manufacturer
Decision
CONFORMIS INC.
SUBSTANTIALLY EQUIVALENT
1
CORIN USA LIMITED
SUBSTANTIALLY EQUIVALENT
1
DEPUY IRELAND UC
SUBSTANTIALLY EQUIVALENT
1
DEPUY ORTHOPAEDICS, INC.
SUBSTANTIALLY EQUIVALENT
1
IMPLANTCAST GMBH
SUBSTANTIALLY EQUIVALENT
1
IMPLANTCAST, GMBH
SUBSTANTIALLY EQUIVALENT
1
SIGNATURE ORTHOPAEDICS PTY LTD.
SUBSTANTIALLY EQUIVALENT
4
STRYKER
SUBSTANTIALLY EQUIVALENT
1
STRYKER ORTHOPAEDICS
SUBSTANTIALLY EQUIVALENT
1
WALDEMAR LINK GMBH & CO. KG
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
335
335
2019
340
340
2020
336
336
2021
373
373
2022
322
322
2023
43
43
Device Problems
MDRs with this Device Problem
Events in those MDRs
Insufficient Information
391
391
Adverse Event Without Identified Device or Use Problem
359
359
Device-Device Incompatibility
217
217
Device Dislodged or Dislocated
196
196
Appropriate Term/Code Not Available
157
157
Break
111
111
Fracture
66
66
Osseointegration Problem
54
54
Loose or Intermittent Connection
47
47
Degraded
39
39
Detachment of Device or Device Component
33
33
Material Erosion
31
31
Loosening of Implant Not Related to Bone-Ingrowth
27
27
Corroded
26
26
Migration
25
25
Unstable
23
23
Loss of Osseointegration
22
22
Malposition of Device
22
22
Naturally Worn
16
16
Device Contaminated During Manufacture or Shipping
15
15
Tear, Rip or Hole in Device Packaging
14
14
Material Deformation
14
14
Noise, Audible
11
11
Inadequacy of Device Shape and/or Size
11
11
Mechanical Problem
10
10
Migration or Expulsion of Device
9
9
Device Appears to Trigger Rejection
8
8
Patient-Device Incompatibility
8
8
Failure to Cut
7
7
Positioning Problem
6
6
Unintended Movement
5
5
Difficult to Insert
5
5
Microbial Contamination of Device
5
5
Inaccurate Information
5
5
Off-Label Use
4
4
Difficult to Remove
4
4
Material Fragmentation
4
4
Defective Device
4
4
Device Contamination with Chemical or Other Material
3
3
Compatibility Problem
3
3
Device Markings/Labelling Problem
3
3
Patient Device Interaction Problem
3
3
Material Integrity Problem
3
3
Component Missing
3
3
Use of Device Problem
3
3
Metal Shedding Debris
2
2
Device Slipped
2
2
Nonstandard Device
2
2
Mechanical Jam
2
2
Packaging Problem
2
2
Deformation Due to Compressive Stress
2
2
Calibration Problem
2
2
Connection Problem
1
1
Data Back-Up Problem
1
1
Device Operates Differently Than Expected
1
1
Device Damaged by Another Device
1
1
Device Packaging Compromised
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Material Protrusion/Extrusion
1
1
Material Twisted/Bent
1
1
Device Handling Problem
1
1
No Apparent Adverse Event
1
1
Scratched Material
1
1
Therapeutic or Diagnostic Output Failure
1
1
Delivered as Unsterile Product
1
1
Material Separation
1
1
Failure to Osseointegrate
1
1
Fitting Problem
1
1
Incomplete or Missing Packaging
1
1
Failure to Align
1
1
Dent in Material
1
1
Loss of or Failure to Bond
1
1
Misconnection
1
1
Crack
1
1
Collapse
1
1
Contamination
1
1
Difficult or Delayed Positioning
1
1
Positioning Failure
1
1
Material Discolored
1
1
Entrapment of Device
1
1
Wrong Label
1
1
Separation Problem
1
1
Difficult or Delayed Separation
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Injury
401
401
Pain
308
308
Unspecified Infection
290
290
Inflammation
196
196
Joint Dislocation
165
165
Reaction
156
156
Foreign Body Reaction
104
104
No Clinical Signs, Symptoms or Conditions
100
100
Insufficient Information
87
87
Metal Related Pathology
78
78
Inadequate Osseointegration
74
74
Failure of Implant
70
70
Bone Fracture(s)
67
67
Ambulation Difficulties
62
62
Fall
56
56
No Known Impact Or Consequence To Patient
50
50
Limb Fracture
49
49
No Consequences Or Impact To Patient
49
49
No Code Available
34
34
Osteolysis
32
32
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
30
30
No Information
26
26
Joint Disorder
25
25
Joint Laxity
23
23
No Patient Involvement
22
22
Discomfort
14
14
Hip Fracture
14
14
Bacterial Infection
14
14
Local Reaction
14
14
Necrosis
10
10
Hematoma
10
10
Loss of Range of Motion
8
8
Tissue Damage
8
8
Muscle/Tendon Damage
8
8
Swelling/ Edema
8
8
Limited Mobility Of The Implanted Joint
7
7
Implant Pain
6
6
Physical Asymmetry
6
6
Host-Tissue Reaction
6
6
Ossification
5
5
Patient Problem/Medical Problem
5
5
Unequal Limb Length
5
5
Fluid Discharge
4
4
Foreign Body In Patient
4
4
Device Embedded In Tissue or Plaque
4
4
Unspecified Tissue Injury
4
4
Abscess
4
4
Wound Dehiscence
4
4
Deformity/ Disfigurement
4
4
Depression
4
4
Weakness
3
3
Synovitis
3
3
Toxicity
3
3
Numbness
3
3
Post Operative Wound Infection
3
3
Osteopenia/ Osteoporosis
3
3
Calcium Deposits/Calcification
3
3
Cyst(s)
3
3
Erythema
3
3
Nerve Damage
3
3
Heart Failure/Congestive Heart Failure
3
3
Not Applicable
2
2
Scar Tissue
2
2
Sepsis
2
2
Seroma
2
2
Hypersensitivity/Allergic reaction
2
2
Hemorrhage/Bleeding
2
2
Muscular Rigidity
2
2
Purulent Discharge
2
2
Granuloma
2
2
Cellulitis
2
2
Erosion
2
2
Blood Loss
2
2
Reaction, Injection Site
2
2
Impaired Healing
2
2
Sweating
1
1
Weight Changes
1
1
Confusion/ Disorientation
1
1
Tachycardia
1
1
Burning Sensation
1
1
Loss of Vision
1
1
Non-union Bone Fracture
1
1
Disability
1
1
Rupture
1
1
Discharge
1
1
Excessive Tear Production
1
1
Distress
1
1
Cardiomyopathy
1
1
Headache
1
1
Edema
1
1
Fatigue
1
1
Flashers
1
1
Irritation
1
1
Hyperplasia
1
1
Skin Discoloration
1
1
Swelling
1
1
Neurological Deficit/Dysfunction
1
1
Necrosis Of Flap Tissue
1
1
Test Result
1
1
Pericarditis
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Biomet, Inc.
II
Dec-17-2020
2
Corin Ltd
II
Sep-30-2021
3
Corin Ltd
II
Jun-11-2021
4
Corin Ltd
II
Mar-22-2021
5
Exactech, Inc.
II
Sep-09-2022
6
Exactech, Inc.
II
Jan-18-2018
7
Signature Orthopaedics Europe Ltd
II
Mar-25-2020
8
Signature Orthopedics Pty Limited
II
May-28-2021
9
Signature Orthopedics Pty Limited
II
Mar-06-2018
10
Waldemar Link GmbH & Co. KG (Mfg Site)
II
Jan-11-2019
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