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TPLC
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Device
prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate
Regulation Description
Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
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
EXACTECH, INC.
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
2
SIGNATURE ORTHOPAEDICS PTY LTD.
SUBSTANTIALLY EQUIVALENT
4
STRYKER
SUBSTANTIALLY EQUIVALENT
1
STRYKER ORTHOPAEDICS
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
337
337
2021
372
372
2022
316
316
2023
334
334
2024
353
353
2025
168
168
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
672
672
Device-Device Incompatibility
335
335
Insufficient Information
193
193
Device Dislodged or Dislocated
166
166
Appropriate Term/Code Not Available
116
116
Osseointegration Problem
94
94
Fracture
58
58
Break
56
56
Detachment of Device or Device Component
50
50
Migration
39
39
Device Appears to Trigger Rejection
37
37
Loosening of Implant Not Related to Bone-Ingrowth
37
37
Degraded
35
35
Material Erosion
34
34
Device Contaminated During Manufacture or Shipping
24
24
Tear, Rip or Hole in Device Packaging
21
21
Corroded
20
20
Naturally Worn
20
20
Unstable
19
19
Loss of Osseointegration
16
16
Loose or Intermittent Connection
13
13
Malposition of Device
10
10
Use of Device Problem
9
9
Inadequacy of Device Shape and/or Size
7
7
Failure to Cut
7
7
Noise, Audible
6
6
Inaccurate Information
6
6
Patient-Device Incompatibility
5
5
Mechanical Problem
4
4
Patient Device Interaction Problem
4
4
Off-Label Use
4
4
Difficult to Insert
4
4
Defective Device
4
4
Compatibility Problem
3
3
Component Missing
3
3
Device Damaged Prior to Use
3
3
Failure to Osseointegrate
3
3
Material Integrity Problem
3
3
Unintended Movement
3
3
No Apparent Adverse Event
3
3
Material Deformation
3
3
Migration or Expulsion of Device
2
2
Incomplete or Missing Packaging
2
2
Difficult to Open or Remove Packaging Material
2
2
Nonstandard Device
2
2
Delivered as Unsterile Product
2
2
Manufacturing, Packaging or Shipping Problem
2
2
Positioning Problem
2
2
Material Fragmentation
2
2
Difficult to Remove
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Unspecified Infection
373
373
Pain
328
328
Insufficient Information
185
185
Metal Related Pathology
156
156
Joint Dislocation
154
154
No Clinical Signs, Symptoms or Conditions
147
147
Limb Fracture
142
142
Foreign Body Reaction
141
141
Inadequate Osseointegration
109
109
Inflammation
102
102
Ambulation Difficulties
88
88
Fall
78
78
Failure of Implant
71
71
Bone Fracture(s)
66
66
Injury
58
58
Reaction
48
48
Joint Laxity
40
40
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
38
38
Osteolysis
36
36
Implant Pain
21
21
No Known Impact Or Consequence To Patient
18
18
No Patient Involvement
17
17
Discomfort
16
16
Bacterial Infection
14
14
Loss of Range of Motion
14
14
Swelling/ Edema
13
13
No Code Available
13
13
Hip Fracture
13
13
Muscle/Tendon Damage
13
13
Local Reaction
13
13
Unequal Limb Length
12
12
Physical Asymmetry
11
11
Necrosis
10
10
Hematoma
9
9
No Information
7
7
Wound Dehiscence
7
7
Unspecified Tissue Injury
6
6
Joint Disorder
5
5
Tissue Damage
5
5
Cyst(s)
5
5
Heart Failure/Congestive Heart Failure
5
5
Fluid Discharge
5
5
Ossification
5
5
No Consequences Or Impact To Patient
5
5
Deformity/ Disfigurement
5
5
Host-Tissue Reaction
4
4
Hemorrhage/Bleeding
4
4
Nerve Damage
4
4
Erythema
4
4
Foreign Body In Patient
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
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