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TPLC
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show TPLC since
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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
2
IMPLANTCAST GMBH
SUBSTANTIALLY EQUIVALENT
1
MAKO SURGICAL CORP.
SUBSTANTIALLY EQUIVALENT
1
MATERIALISE NV
SUBSTANTIALLY EQUIVALENT
2
MEDACTA INTERNATIONAL S.A.
SUBSTANTIALLY EQUIVALENT
1
MEDACTA INTERNATIONAL SA
SUBSTANTIALLY EQUIVALENT
1
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
2018
159
159
2019
177
177
2020
273
273
2021
240
240
2022
259
259
2023
148
148
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
337
337
Break
151
151
Fracture
140
140
Insufficient Information
105
105
Loosening of Implant Not Related to Bone-Ingrowth
93
93
Appropriate Term/Code Not Available
82
82
Migration
32
32
Loose or Intermittent Connection
30
30
Crack
27
27
Unstable
27
27
Difficult to Insert
21
21
Naturally Worn
20
20
Mechanical Jam
19
19
Malposition of Device
18
18
Connection Problem
16
16
Device Dislodged or Dislocated
16
16
Flaked
15
15
Migration or Expulsion of Device
14
14
Loss of Osseointegration
13
13
Material Fragmentation
13
13
Loss of or Failure to Bond
10
10
Device Appears to Trigger Rejection
10
10
Noise, Audible
10
10
Material Deformation
8
8
Material Twisted/Bent
8
8
Failure to Osseointegrate
7
7
Fitting Problem
7
7
Corroded
7
7
Positioning Failure
7
7
Material Protrusion/Extrusion
6
6
Defective Device
5
5
Degraded
5
5
Mechanical Problem
5
5
Physical Resistance/Sticking
5
5
No Apparent Adverse Event
4
4
Incomplete or Inadequate Connection
4
4
Material Erosion
4
4
Inadequacy of Device Shape and/or Size
4
4
Manufacturing, Packaging or Shipping Problem
4
4
Device Damaged by Another Device
4
4
Patient Device Interaction Problem
4
4
Packaging Problem
3
3
Detachment of Device or Device Component
3
3
Peeled/Delaminated
3
3
Difficult To Position
3
3
Off-Label Use
2
2
Overheating of Device
2
2
Unsealed Device Packaging
2
2
Device Damaged Prior to Use
2
2
Microbial Contamination of Device
2
2
Biocompatibility
2
2
Contamination /Decontamination Problem
2
2
Material Separation
2
2
Expiration Date Error
2
2
Positioning Problem
2
2
Scratched Material
1
1
Unintended Movement
1
1
Material Integrity Problem
1
1
Output Problem
1
1
Patient-Device Incompatibility
1
1
Activation, Positioning or Separation Problem
1
1
Device Operational Issue
1
1
Device Packaging Compromised
1
1
Device Contaminated During Manufacture or Shipping
1
1
Tear, Rip or Hole in Device Packaging
1
1
Difficult to Remove
1
1
Material Rupture
1
1
Cut In Material
1
1
Dent in Material
1
1
Device Slipped
1
1
Smoking
1
1
Unexpected Therapeutic Results
1
1
Incorrect Measurement
1
1
Difficult or Delayed Positioning
1
1
Material Discolored
1
1
Device Reprocessing Problem
1
1
Contamination
1
1
Unintended Application Program Shut Down
1
1
Material Split, Cut or Torn
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pain
308
308
No Clinical Signs, Symptoms or Conditions
235
235
Unspecified Infection
121
121
Failure of Implant
107
107
No Known Impact Or Consequence To Patient
85
85
Bone Fracture(s)
84
84
Injury
80
80
Insufficient Information
57
57
No Information
55
55
Inadequate Osseointegration
40
40
No Consequences Or Impact To Patient
37
37
Swelling
36
36
Loss of Range of Motion
32
32
Ambulation Difficulties
25
25
Swelling/ Edema
24
24
Limited Mobility Of The Implanted Joint
22
22
Joint Laxity
21
21
No Code Available
20
20
No Patient Involvement
20
20
Joint Dislocation
19
19
Foreign Body In Patient
18
18
Fall
17
17
Arthralgia
15
15
Osteolysis
15
15
Device Embedded In Tissue or Plaque
13
13
Implant Pain
12
12
Inflammation
12
12
Arthritis
12
12
Discomfort
9
9
Numbness
8
8
Synovitis
8
8
Joint Disorder
7
7
Osteopenia/ Osteoporosis
7
7
Metal Related Pathology
7
7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
6
6
Patient Problem/Medical Problem
5
5
Reaction
5
5
Unspecified Tissue Injury
4
4
Necrosis
4
4
Joint Swelling
4
4
Cyst(s)
4
4
Wound Dehiscence
3
3
Abscess
3
3
Damage to Ligament(s)
3
3
Embolism/Embolus
3
3
Toxicity
2
2
Muscular Rigidity
2
2
Laceration(s)
2
2
Deformity/ Disfigurement
2
2
Hematoma
2
2
Hemorrhage/Bleeding
2
2
Erosion
2
2
Cellulitis
1
1
Debris, Bone Shedding
1
1
Edema
1
1
Ossification
1
1
Bacterial Infection
1
1
Fatigue
1
1
Infiltration into Tissue
1
1
Nerve Damage
1
1
Weakness
1
1
Scar Tissue
1
1
Skin Discoloration
1
1
Inadequate Pain Relief
1
1
Post Operative Wound Infection
1
1
Thromboembolism
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
7
Zimmer Biomet, Inc.
II
Mar-28-2018
8
Zimmer Biomet, Inc.
II
Mar-14-2018
9
Zimmer Biomet, Inc.
II
Jan-14-2018
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