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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
CORIN USA LIMITED
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
NEXTSTEP ARTHROPEDIX
SUBSTANTIALLY EQUIVALENT
1
ORTHO DEVELOPMENT CORP.
SUBSTANTIALLY EQUIVALENT
1
SIGNATURE ORTHOPAEDICS PTY LTD
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
336
336
2020
337
337
2021
372
372
2022
316
316
2023
335
335
2024
273
273
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
575
575
Device-Device Incompatibility
316
316
Insufficient Information
282
282
Device Dislodged or Dislocated
182
182
Appropriate Term/Code Not Available
153
153
Break
96
96
Osseointegration Problem
78
78
Fracture
64
64
Degraded
51
51
Detachment of Device or Device Component
49
49
Migration
42
42
Loosening of Implant Not Related to Bone-Ingrowth
40
40
Loose or Intermittent Connection
36
36
Material Erosion
35
35
Corroded
25
25
Device Appears to Trigger Rejection
24
24
Device Contaminated During Manufacture or Shipping
23
23
Unstable
22
22
Tear, Rip or Hole in Device Packaging
22
22
Naturally Worn
16
16
Loss of Osseointegration
14
14
Malposition of Device
14
14
Inadequacy of Device Shape and/or Size
8
8
Use of Device Problem
8
8
Failure to Cut
7
7
Noise, Audible
6
6
Inaccurate Information
6
6
Material Deformation
6
6
Mechanical Problem
6
6
Unintended Movement
6
6
Patient-Device Incompatibility
6
6
Migration or Expulsion of Device
5
5
Patient Device Interaction Problem
4
4
Material Integrity Problem
4
4
Difficult to Insert
4
4
Defective Device
4
4
Off-Label Use
4
4
Compatibility Problem
3
3
Difficult to Remove
3
3
Positioning Problem
3
3
Component Missing
3
3
Nonstandard Device
3
3
Device Damaged Prior to Use
3
3
No Apparent Adverse Event
3
3
Material Fragmentation
2
2
Manufacturing, Packaging or Shipping Problem
2
2
Mechanical Jam
2
2
Failure to Osseointegrate
2
2
Delivered as Unsterile Product
2
2
Calibration Problem
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Unspecified Infection
357
357
Pain
335
335
Injury
209
209
Metal Related Pathology
157
157
Insufficient Information
151
151
Joint Dislocation
146
146
Inflammation
138
138
No Clinical Signs, Symptoms or Conditions
134
134
Foreign Body Reaction
131
131
Limb Fracture
123
123
Inadequate Osseointegration
95
95
Reaction
90
90
Failure of Implant
78
78
Fall
73
73
Bone Fracture(s)
70
70
Ambulation Difficulties
65
65
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
37
37
Osteolysis
36
36
Joint Laxity
34
34
No Code Available
24
24
No Patient Involvement
21
21
Joint Disorder
16
16
Discomfort
16
16
Implant Pain
16
16
Hip Fracture
15
15
Loss of Range of Motion
15
15
Local Reaction
14
14
Bacterial Infection
12
12
Physical Asymmetry
11
11
Swelling/ Edema
11
11
No Information
11
11
Muscle/Tendon Damage
11
11
Unequal Limb Length
10
10
Necrosis
10
10
Hematoma
9
9
Wound Dehiscence
7
7
Unspecified Tissue Injury
6
6
Ossification
6
6
Heart Failure/Congestive Heart Failure
5
5
Host-Tissue Reaction
5
5
Tissue Damage
5
5
Hemorrhage/Bleeding
5
5
Deformity/ Disfigurement
5
5
Cyst(s)
5
5
Foreign Body In Patient
4
4
Fluid Discharge
4
4
Erythema
4
4
Nerve Damage
4
4
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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