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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
CONFORMIS INC.
SUBSTANTIALLY EQUIVALENT
1
DEPUY IRELAND UC
SUBSTANTIALLY EQUIVALENT
2
DEPUY ORTHOPAEDICS, INC.
SUBSTANTIALLY EQUIVALENT
1
IMPLANTCAST GMBH
SUBSTANTIALLY EQUIVALENT
1
IMPLANTCAST, GMBH
SUBSTANTIALLY EQUIVALENT
1
ORTHO DEVELOPMENT CORP.
SUBSTANTIALLY EQUIVALENT
1
SIGNATURE ORTHOPAEDICS PTY LTD.
SUBSTANTIALLY EQUIVALENT
4
STRYKER
SUBSTANTIALLY EQUIVALENT
1
STRYKER ORTHOPAEDICS
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
340
340
2020
337
337
2021
372
372
2022
316
316
2023
334
334
2024
62
62
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
493
493
Device-Device Incompatibility
287
287
Insufficient Information
257
257
Device Dislodged or Dislocated
172
172
Appropriate Term/Code Not Available
149
149
Break
96
96
Osseointegration Problem
67
67
Fracture
57
57
Detachment of Device or Device Component
44
44
Degraded
43
43
Loose or Intermittent Connection
36
36
Material Erosion
34
34
Migration
34
34
Loosening of Implant Not Related to Bone-Ingrowth
33
33
Corroded
22
22
Unstable
22
22
Device Contaminated During Manufacture or Shipping
21
21
Device Appears to Trigger Rejection
18
18
Tear, Rip or Hole in Device Packaging
15
15
Loss of Osseointegration
14
14
Malposition of Device
14
14
Naturally Worn
13
13
Inadequacy of Device Shape and/or Size
8
8
Failure to Cut
7
7
Patient-Device Incompatibility
6
6
Material Deformation
6
6
Noise, Audible
6
6
Unintended Movement
6
6
Use of Device Problem
6
6
Mechanical Problem
6
6
Inaccurate Information
6
6
Migration or Expulsion of Device
5
5
Difficult to Insert
4
4
Off-Label Use
4
4
Defective Device
4
4
Material Integrity Problem
3
3
Patient Device Interaction Problem
3
3
Compatibility Problem
3
3
Positioning Problem
3
3
Component Missing
3
3
Difficult to Remove
3
3
Nonstandard Device
3
3
Delivered as Unsterile Product
2
2
Material Fragmentation
2
2
Mechanical Jam
2
2
No Apparent Adverse Event
2
2
Calibration Problem
2
2
Connection Problem
1
1
Data Back-Up Problem
1
1
Device Markings/Labelling Problem
1
1
Device Damaged by Another Device
1
1
Deformation Due to Compressive Stress
1
1
Material Protrusion/Extrusion
1
1
Material Twisted/Bent
1
1
Device Contamination with Chemical or Other Material
1
1
Difficult to Open or Remove Packaging Material
1
1
Device Handling Problem
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Scratched Material
1
1
Therapeutic or Diagnostic Output Failure
1
1
Packaging Problem
1
1
Misconnection
1
1
Crack
1
1
Collapse
1
1
Difficult or Delayed Positioning
1
1
Positioning Failure
1
1
Entrapment of Device
1
1
Peeled/Delaminated
1
1
Material Separation
1
1
Failure to Osseointegrate
1
1
Fitting Problem
1
1
Device Damaged Prior to Use
1
1
Microbial Contamination of Device
1
1
Incomplete or Missing Packaging
1
1
Failure to Align
1
1
Expiration Date Error
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
Unspecified Infection
314
314
Pain
304
304
Injury
213
213
Inflammation
142
142
Joint Dislocation
136
136
Metal Related Pathology
136
136
Foreign Body Reaction
127
127
No Clinical Signs, Symptoms or Conditions
121
121
Insufficient Information
101
101
Limb Fracture
96
96
Reaction
95
95
Inadequate Osseointegration
82
82
Failure of Implant
71
71
Bone Fracture(s)
64
64
Fall
62
62
Ambulation Difficulties
61
61
No Consequences Or Impact To Patient
49
49
No Known Impact Or Consequence To Patient
40
40
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
36
36
Joint Laxity
31
31
Osteolysis
29
29
No Code Available
24
24
No Patient Involvement
21
21
Joint Disorder
16
16
Local Reaction
14
14
Discomfort
13
13
Hip Fracture
13
13
Loss of Range of Motion
12
12
Bacterial Infection
12
12
Implant Pain
12
12
Physical Asymmetry
11
11
No Information
11
11
Swelling/ Edema
10
10
Muscle/Tendon Damage
10
10
Unequal Limb Length
9
9
Necrosis
9
9
Hematoma
9
9
Ossification
6
6
Unspecified Tissue Injury
6
6
Heart Failure/Congestive Heart Failure
5
5
Wound Dehiscence
5
5
Host-Tissue Reaction
5
5
Hemorrhage/Bleeding
5
5
Deformity/ Disfigurement
5
5
Tissue Damage
5
5
Nerve Damage
4
4
Cyst(s)
4
4
Fluid Discharge
4
4
Foreign Body In Patient
4
4
Patient Problem/Medical Problem
3
3
Osteopenia/ Osteoporosis
3
3
Limited Mobility Of The Implanted Joint
3
3
Abscess
3
3
Hypersensitivity/Allergic reaction
3
3
Erythema
3
3
Synovitis
3
3
Toxicity
3
3
Numbness
3
3
Distress
2
2
Arthralgia
2
2
Weakness
2
2
Swelling
2
2
Sepsis
2
2
Seroma
2
2
Fatigue
2
2
Neuropathy
2
2
Menstrual Irregularities
2
2
Muscular Rigidity
2
2
Purulent Discharge
2
2
Cardiomyopathy
2
2
Cellulitis
2
2
Granuloma
2
2
Post Operative Wound Infection
2
2
Thrombosis/Thrombus
2
2
Pericarditis
1
1
Cancer
1
1
Paresthesia
1
1
Embolism/Embolus
1
1
Test Result
1
1
Device Embedded In Tissue or Plaque
1
1
Unspecified Musculoskeletal problem
1
1
Localized Skin Lesion
1
1
Malunion of Bone
1
1
Headache
1
1
Adhesion(s)
1
1
Erosion
1
1
Pulmonary Embolism
1
1
Paralysis
1
1
Muscle Weakness
1
1
Flashers
1
1
Irritation
1
1
Skin Discoloration
1
1
Scar Tissue
1
1
Loss of Vision
1
1
Burning Sensation
1
1
Rupture
1
1
Discharge
1
1
Anxiety
1
1
Scar Excision
1
1
Non-union Bone Fracture
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
Signature Orthopaedics Europe Ltd
II
Mar-25-2020
7
Signature Orthopedics Pty Limited
II
May-28-2021
8
Waldemar Link GmbH & Co. KG (Mfg Site)
II
Jan-11-2019
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