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Device
prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer
Regulation Description
Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
Product Code
HSX
Regulation Number
888.3520
Device Class
2
Premarket Reviews
Manufacturer
Decision
ARTHREX INC.
SUBSTANTIALLY EQUIVALENT
1
BODYCAD LABORATORIES, INC.
SUBSTANTIALLY EQUIVALENT
3
GLOBUS MEDICAL, INC
SUBSTANTIALLY EQUIVALENT
1
HOWMEDICA OSTEONICS CORP AKA STRYKER ORTHOPAEDICS
SUBSTANTIALLY EQUIVALENT
1
IMPLANTCAST GMBH
SUBSTANTIALLY EQUIVALENT
1
KYOCERA MEDICAL TECHNOLOGIES INC.
SUBSTANTIALLY EQUIVALENT
1
MAKO SURGICAL CORP.
SUBSTANTIALLY EQUIVALENT
1
MATERIALISE NV
SUBSTANTIALLY EQUIVALENT
1
MEDACTA INTERNATIONAL S.A.
SUBSTANTIALLY EQUIVALENT
1
ORTHO DEVELOPMENT CORPORATION
SUBSTANTIALLY EQUIVALENT
1
OVERTURE ORTHOPAEDICS
SUBSTANTIALLY EQUIVALENT
1
OVERTURE RESURFACING INC.
SUBSTANTIALLY EQUIVALENT
1
SIGNATURE ORTHOPAEDICS PTY LTD.
SUBSTANTIALLY EQUIVALENT
1
SMITH & NEPHEW, INC.
SUBSTANTIALLY EQUIVALENT
2
ZIMMER, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
273
273
2021
240
240
2022
258
258
2023
231
231
2024
172
172
2025
71
154
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
418
501
Fracture
192
248
Break
130
130
Loosening of Implant Not Related to Bone-Ingrowth
102
129
Appropriate Term/Code Not Available
66
66
Migration
32
32
Crack
26
26
Device Dislodged or Dislocated
25
25
Naturally Worn
22
22
Mechanical Jam
21
21
Device Appears to Trigger Rejection
20
20
Flaked
19
19
Unstable
18
18
Material Fragmentation
17
17
Connection Problem
16
16
Malposition of Device
15
15
Loss of Osseointegration
15
15
Difficult to Insert
15
15
Positioning Failure
14
14
Insufficient Information
13
13
Fitting Problem
12
12
Loose or Intermittent Connection
10
10
Loss of or Failure to Bond
10
10
Material Deformation
9
9
Failure to Osseointegrate
8
8
Noise, Audible
7
7
Material Twisted/Bent
7
7
Corroded
7
7
Degraded
7
7
Material Erosion
7
23
Device Damaged by Another Device
6
6
Material Protrusion/Extrusion
6
6
Defective Device
6
6
Detachment of Device or Device Component
5
5
Patient Device Interaction Problem
5
5
Separation Failure
5
5
Osseointegration Problem
4
60
Manufacturing, Packaging or Shipping Problem
4
4
Inadequacy of Device Shape and/or Size
4
4
Packaging Problem
3
3
Incomplete or Inadequate Connection
3
3
Migration or Expulsion of Device
3
3
Peeled/Delaminated
3
3
Use of Device Problem
3
3
Biocompatibility
2
2
Expiration Date Error
2
2
Microbial Contamination of Device
2
2
Improper or Incorrect Procedure or Method
2
2
Material Separation
2
2
Unsealed Device Packaging
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
314
314
Pain
296
352
Failure of Implant
121
121
Unspecified Infection
109
176
Insufficient Information
94
177
Bone Fracture(s)
68
68
No Known Impact Or Consequence To Patient
58
58
Inadequate Osseointegration
52
52
Joint Laxity
40
112
Swelling/ Edema
32
32
Loss of Range of Motion
28
28
Joint Dislocation
28
28
Device Embedded In Tissue or Plaque
25
25
Foreign Body In Patient
25
25
No Information
24
24
Implant Pain
21
21
Arthralgia
21
37
Swelling
19
19
Fall
18
18
No Patient Involvement
18
18
Arthritis
16
32
No Consequences Or Impact To Patient
16
16
Ambulation Difficulties
15
15
Osteolysis
15
31
Injury
15
15
Inflammation
12
12
Metal Related Pathology
11
11
Discomfort
10
10
Limited Mobility Of The Implanted Joint
9
9
Synovitis
9
9
No Code Available
9
9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
9
9
Numbness
8
8
Osteopenia/ Osteoporosis
7
7
Reaction
5
5
Damage to Ligament(s)
5
5
Cyst(s)
4
4
Joint Disorder
4
4
Unspecified Tissue Injury
4
4
Hematoma
3
59
Deformity/ Disfigurement
3
3
Joint Swelling
3
3
Patient Problem/Medical Problem
3
3
Scar Tissue
3
3
Embolism/Embolus
3
3
Hemorrhage/Bleeding
2
2
Erosion
2
2
Adhesion(s)
2
2
Wound Dehiscence
2
2
Necrosis
2
2
Recalls
Manufacturer
Recall Class
Date Posted
1
Encore Medical, LP
II
Nov-20-2020
2
Howmedica Osteonics Corp.
II
Apr-12-2023
3
Linkbio Corp.
II
May-04-2023
4
Smith & Nephew, Inc.
II
May-31-2023
5
Smith & Nephew, Inc.
II
Apr-14-2023
6
Smith & Nephew, Inc.
II
May-27-2020
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