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TPLC
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show TPLC since
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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
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
341
341
2020
337
337
2021
372
372
2022
316
316
2023
335
335
2024
215
215
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
546
546
Device-Device Incompatibility
313
313
Insufficient Information
285
285
Device Dislodged or Dislocated
180
180
Appropriate Term/Code Not Available
152
152
Break
96
96
Osseointegration Problem
74
74
Fracture
61
61
Detachment of Device or Device Component
49
49
Degraded
49
49
Migration
38
38
Loosening of Implant Not Related to Bone-Ingrowth
37
37
Loose or Intermittent Connection
36
36
Material Erosion
35
35
Corroded
25
25
Device Appears to Trigger Rejection
23
23
Unstable
22
22
Device Contaminated During Manufacture or Shipping
22
22
Tear, Rip or Hole in Device Packaging
21
21
Loss of Osseointegration
14
14
Malposition of Device
14
14
Naturally Worn
13
13
Inadequacy of Device Shape and/or Size
8
8
Use of Device Problem
8
8
Failure to Cut
7
7
Noise, Audible
6
6
Mechanical Problem
6
6
Inaccurate Information
6
6
Patient-Device Incompatibility
6
6
Unintended Movement
6
6
Material Deformation
6
6
Migration or Expulsion of Device
5
5
Patient Device Interaction Problem
4
4
Off-Label Use
4
4
Difficult to Insert
4
4
Defective Device
4
4
Compatibility Problem
3
3
Nonstandard Device
3
3
Device Damaged Prior to Use
3
3
No Apparent Adverse Event
3
3
Material Integrity Problem
3
3
Component Missing
3
3
Positioning Problem
3
3
Difficult to Remove
3
3
Manufacturing, Packaging or Shipping Problem
2
2
Failure to Osseointegrate
2
2
Delivered as Unsterile Product
2
2
Calibration Problem
2
2
Material Fragmentation
2
2
Incomplete or Missing Packaging
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Unspecified Infection
344
344
Pain
324
324
Injury
214
214
Metal Related Pathology
151
151
Insufficient Information
144
144
Joint Dislocation
144
144
Inflammation
142
142
No Clinical Signs, Symptoms or Conditions
132
132
Foreign Body Reaction
131
131
Limb Fracture
111
111
Reaction
95
95
Inadequate Osseointegration
92
92
Failure of Implant
75
75
Fall
69
69
Bone Fracture(s)
68
68
Ambulation Difficulties
64
64
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
Joint Laxity
33
33
Osteolysis
32
32
No Code Available
24
24
No Patient Involvement
21
21
Joint Disorder
16
16
Implant Pain
15
15
Local Reaction
14
14
Hip Fracture
13
13
Discomfort
13
13
Loss of Range of Motion
12
12
Bacterial Infection
12
12
No Information
11
11
Muscle/Tendon Damage
11
11
Physical Asymmetry
11
11
Swelling/ Edema
10
10
Necrosis
10
10
Unequal Limb Length
10
10
Hematoma
9
9
Wound Dehiscence
7
7
Unspecified Tissue Injury
6
6
Ossification
6
6
Host-Tissue Reaction
5
5
Heart Failure/Congestive Heart Failure
5
5
Tissue Damage
5
5
Hemorrhage/Bleeding
5
5
Deformity/ Disfigurement
5
5
Cyst(s)
4
4
Fluid Discharge
4
4
Nerve Damage
4
4
Foreign Body In Patient
4
4
Toxicity
3
3
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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