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TPLC
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show TPLC since
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2024
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Device
prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer
Product Code
HSX
Regulation Number
888.3520
Device Class
2
Premarket Reviews
Manufacturer
Decision
ARTHREX INC.
SUBSTANTIALLY EQUIVALENT
1
BODYCAD LABORATORIES INC.
SUBSTANTIALLY EQUIVALENT
1
BODYCAD LABORATORIES, INC.
SUBSTANTIALLY EQUIVALENT
5
ENCORE MEDICAL, L.P.
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
MEDACTA INTERNATIONAL SA
SUBSTANTIALLY EQUIVALENT
1
1. K183029
MOTO Partial Knee System
ORTHO DEVELOPMENT CORPORATION
SUBSTANTIALLY EQUIVALENT
1
OVERTURE RESURFACING INC.
SUBSTANTIALLY EQUIVALENT
1
SIGNATURE ORTHOPAEDICS PTY LTD.
SUBSTANTIALLY EQUIVALENT
1
SMITH & NEPHEW INC
SUBSTANTIALLY EQUIVALENT
1
SMITH & NEPHEW, INC.
SUBSTANTIALLY EQUIVALENT
2
ZIMMER, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
177
177
2020
273
273
2021
240
240
2022
259
259
2023
231
231
2024
44
44
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
358
358
Fracture
168
168
Break
145
145
Loosening of Implant Not Related to Bone-Ingrowth
99
99
Appropriate Term/Code Not Available
73
73
Insufficient Information
54
54
Migration
34
34
Crack
27
27
Unstable
26
26
Device Dislodged or Dislocated
23
23
Loose or Intermittent Connection
22
22
Mechanical Jam
21
21
Naturally Worn
20
20
Difficult to Insert
19
19
Flaked
16
16
Connection Problem
16
16
Malposition of Device
14
14
Device Appears to Trigger Rejection
14
14
Loss of Osseointegration
14
14
Material Fragmentation
13
13
Fitting Problem
12
12
Loss of or Failure to Bond
10
10
Positioning Failure
9
9
Material Deformation
9
9
Material Twisted/Bent
9
9
Noise, Audible
9
9
Failure to Osseointegrate
8
8
Corroded
7
7
Degraded
6
6
Material Protrusion/Extrusion
6
6
Migration or Expulsion of Device
5
5
Material Erosion
4
4
Device Damaged by Another Device
4
4
Manufacturing, Packaging or Shipping Problem
4
4
Defective Device
4
4
Patient Device Interaction Problem
4
4
Incomplete or Inadequate Connection
4
4
Packaging Problem
3
3
Inadequacy of Device Shape and/or Size
3
3
Material Separation
2
2
Peeled/Delaminated
2
2
Improper or Incorrect Procedure or Method
2
2
Device Damaged Prior to Use
2
2
Microbial Contamination of Device
2
2
Overheating of Device
2
2
Mechanical Problem
2
2
Osseointegration Problem
2
2
Physical Resistance/Sticking
2
2
Detachment of Device or Device Component
2
2
Expiration Date Error
2
2
Separation Failure
2
2
Biocompatibility
2
2
Contamination /Decontamination Problem
2
2
Activation, Positioning or Separation Problem
1
1
Patient-Device Incompatibility
1
1
Material Integrity Problem
1
1
Unintended Application Program Shut Down
1
1
Material Split, Cut or Torn
1
1
Output Problem
1
1
Positioning Problem
1
1
Scratched Material
1
1
No Apparent Adverse Event
1
1
Mechanics Altered
1
1
Unsealed Device Packaging
1
1
Material Discolored
1
1
Device Reprocessing Problem
1
1
Tear, Rip or Hole in Device Packaging
1
1
Dent in Material
1
1
Off-Label Use
1
1
Difficult to Remove
1
1
Material Rupture
1
1
Smoking
1
1
Unexpected Therapeutic Results
1
1
Premature Separation
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pain
307
307
No Clinical Signs, Symptoms or Conditions
266
266
Failure of Implant
117
117
Unspecified Infection
115
115
Insufficient Information
73
73
No Known Impact Or Consequence To Patient
72
72
Bone Fracture(s)
67
67
Injury
52
52
Inadequate Osseointegration
45
45
No Information
35
35
No Consequences Or Impact To Patient
30
30
Swelling
29
29
Joint Laxity
29
29
Loss of Range of Motion
27
27
Swelling/ Edema
26
26
Ambulation Difficulties
25
25
Joint Dislocation
25
25
Foreign Body In Patient
22
22
Device Embedded In Tissue or Plaque
21
21
Fall
19
19
No Patient Involvement
18
18
Arthralgia
16
16
Osteolysis
15
15
Limited Mobility Of The Implanted Joint
15
15
Implant Pain
15
15
Inflammation
12
12
No Code Available
11
11
Metal Related Pathology
10
10
Arthritis
10
10
Synovitis
9
9
Discomfort
8
8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
8
8
Numbness
8
8
Osteopenia/ Osteoporosis
7
7
Joint Disorder
5
5
Reaction
5
5
Damage to Ligament(s)
5
5
Necrosis
5
5
Cyst(s)
4
4
Wound Dehiscence
4
4
Unspecified Tissue Injury
4
4
Embolism/Embolus
3
3
Joint Swelling
3
3
Deformity/ Disfigurement
3
3
Patient Problem/Medical Problem
3
3
Abscess
3
3
Scar Tissue
3
3
Muscular Rigidity
2
2
Adhesion(s)
2
2
Laceration(s)
2
2
Erosion
2
2
Hematoma
2
2
Hemorrhage/Bleeding
2
2
Infiltration into Tissue
1
1
Ossification
1
1
Debris, Bone Shedding
1
1
Bacterial Infection
1
1
Nerve Damage
1
1
Sepsis
1
1
Toxicity
1
1
Rupture
1
1
Weakness
1
1
Burning Sensation
1
1
Thromboembolism
1
1
Post Operative Wound Infection
1
1
Muscle/Tendon Damage
1
1
Skin Inflammation/ Irritation
1
1
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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