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TPLC
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show TPLC since
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Device
prosthesis, knee, femorotibial, semi-constrained, cemented, metal/polymer
Product Code
HRY
Regulation Number
888.3530
Device Class
2
Premarket Reviews
Manufacturer
Decision
DEPUY IRELAND UC
SUBSTANTIALLY EQUIVALENT
1
NANOORTHO, LLC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2017
402
402
2018
613
613
2019
367
367
2020
1055
1055
2021
1222
1222
2022
351
351
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
1259
1259
Insufficient Information
549
549
Adverse Event Without Identified Device or Use Problem
360
360
Naturally Worn
237
237
Loosening of Implant Not Related to Bone-Ingrowth
184
184
Loose or Intermittent Connection
154
154
Unstable
141
141
Crack
136
136
Appropriate Term/Code Not Available
123
123
Fracture
111
111
Device Dislodged or Dislocated
100
100
Connection Problem
66
66
Material Deformation
56
56
Detachment of Device or Device Component
55
55
Migration or Expulsion of Device
50
50
Loss of Osseointegration
46
46
Mechanical Problem
40
40
Defective Device
39
39
Component Missing
39
39
Dull, Blunt
37
37
Loss of or Failure to Bond
37
37
Mechanical Jam
36
36
Difficult to Insert
35
35
Material Fragmentation
32
32
Malposition of Device
30
30
Material Separation
27
27
Patient Device Interaction Problem
27
27
Incomplete or Inadequate Connection
22
22
Device Contamination with Chemical or Other Material
21
21
Noise, Audible
20
20
Material Twisted/Bent
20
20
Migration
19
19
Unintended Movement
19
19
Device-Device Incompatibility
17
17
Material Integrity Problem
16
16
Patient-Device Incompatibility
16
16
Device Markings/Labelling Problem
14
14
Physical Resistance/Sticking
13
13
Device Reprocessing Problem
12
12
Fitting Problem
11
11
Use of Device Problem
10
10
Failure to Align
9
9
Contamination /Decontamination Problem
9
9
Mechanics Altered
9
9
Osseointegration Problem
8
8
Inadequacy of Device Shape and/or Size
7
7
Improper or Incorrect Procedure or Method
7
7
Material Discolored
7
7
Tear, Rip or Hole in Device Packaging
6
6
Positioning Problem
6
6
Scratched Material
6
6
No Apparent Adverse Event
5
5
Packaging Problem
5
5
Device Damaged Prior to Use
5
5
Corroded
5
5
Detachment Of Device Component
5
5
Positioning Failure
5
5
Flaked
5
5
Misassembled
4
4
Failure to Disconnect
4
4
Separation Failure
3
3
Structural Problem
3
3
Device Operates Differently Than Expected
3
3
Manufacturing, Packaging or Shipping Problem
3
3
Premature Separation
3
3
Material Split, Cut or Torn
3
3
Delivered as Unsterile Product
3
3
Material Erosion
3
3
Biocompatibility
3
3
Shipping Damage or Problem
3
3
Peeled/Delaminated
3
3
Off-Label Use
3
3
Difficult to Remove
3
3
Material Too Rigid or Stiff
2
2
Unsealed Device Packaging
2
2
Device Appears to Trigger Rejection
2
2
Disassembly
2
2
Misconnection
2
2
Nonstandard Device
2
2
Component Falling
2
2
Partial Blockage
2
2
Failure to Charge
2
2
Separation Problem
2
2
Device Fell
2
2
No Fail-Safe Mechanism
2
2
Device Packaging Compromised
2
2
Activation, Positioning or SeparationProblem
2
2
Device Contaminated During Manufacture or Shipping
2
2
Material Distortion
1
1
Device Damaged by Another Device
1
1
Moisture or Humidity Problem
1
1
Torn Material
1
1
Programming Issue
1
1
Audible Prompt/Feedback Problem
1
1
Sharp Edges
1
1
Component Misassembled
1
1
Misassembly During Maintenance/Repair
1
1
Thickening of Material
1
1
Degraded
1
1
Difficult or Delayed Positioning
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1519
1519
No Information
498
498
Pain
495
495
No Known Impact Or Consequence To Patient
243
243
Unspecified Infection
240
240
No Consequences Or Impact To Patient
221
221
No Code Available
219
219
No Patient Involvement
169
169
Failure of Implant
108
108
Ambulation Difficulties
100
100
Injury
100
100
Insufficient Information
90
90
Joint Dislocation
69
69
Bone Fracture(s)
63
63
Swelling/ Edema
62
62
Joint Laxity
58
58
Loss of Range of Motion
56
56
Osteolysis
54
54
Not Applicable
54
54
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
34
34
Swelling
34
34
Synovitis
24
24
Foreign Body In Patient
21
21
Inadequate Osseointegration
16
16
Discomfort
15
15
Muscular Rigidity
15
15
Fall
14
14
Hemorrhage/Bleeding
13
13
Limited Mobility Of The Implanted Joint
13
13
Joint Disorder
12
12
Hypersensitivity/Allergic reaction
12
12
Adhesion(s)
12
12
Arthritis
11
11
Post Operative Wound Infection
11
11
Reaction
11
11
Death
9
9
Inflammation
9
9
Neck Stiffness
8
8
Scar Tissue
6
6
Thrombosis
6
6
Fatigue
6
6
Cellulitis
6
6
Pulmonary Embolism
5
5
Device Embedded In Tissue or Plaque
5
5
Implant Pain
5
5
Unspecified Tissue Injury
4
4
Metal Related Pathology
4
4
Thrombosis/Thrombus
4
4
Numbness
4
4
Joint Swelling
4
4
Cyst(s)
4
4
Damage to Ligament(s)
4
4
Laceration(s)
3
3
Hematoma
3
3
Autoimmune Reaction
3
3
Bacterial Infection
3
3
Foreign Body Reaction
3
3
Ossification
3
3
Tissue Damage
3
3
Urinary Tract Infection
3
3
Burning Sensation
3
3
Sepsis
3
3
Patient Problem/Medical Problem
3
3
Unspecified Musculoskeletal problem
3
3
Vascular Dissection
2
2
Edema
2
2
High Blood Pressure/ Hypertension
2
2
Low Blood Pressure/ Hypotension
2
2
Rash
2
2
Renal Failure
2
2
Phlebitis
1
1
Muscle Weakness
1
1
Irritation
1
1
Embolism
1
1
Host-Tissue Reaction
1
1
Syncope
1
1
Aspiration/Inhalation
1
1
Autoimmune Disorder
1
1
Fibrosis
1
1
Tissue Breakdown
1
1
Alteration In Body Temperature
1
1
Osteopenia/ Osteoporosis
1
1
Scarring
1
1
Deformity/ Disfigurement
1
1
Non-union Bone Fracture
1
1
Muscle/Tendon Damage
1
1
Breast Discomfort/Pain
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Aesculap Implant Systems LLC
II
Sep-22-2021
2
Biomet, Inc.
II
Dec-17-2020
3
Biomet, Inc.
II
May-28-2020
4
DePuy Orthopaedics, Inc.
II
Mar-20-2018
5
Exactech, Inc.
II
Oct-04-2021
6
Zimmer Biomet, Inc.
II
Mar-27-2017
7
Zimmer Biomet, Inc.
II
Jan-06-2017
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